Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly (Fruisenior)

Overview

To develop more natural fruit pastes matrices that can effectively act as carbohydrate vectors in the elderly population and that are part of a normal diet while maintaining the pleasure of eating.

Full Title of Study: “Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly: Proof of Clinical Concept”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 15, 2021

Detailed Description

This is an interventional randomized, single blinded, cross over and controlled study. The main objective is the study of the kinetic modification of blood glucose with the "fruit" matrices enriched in maltodextrins, fructose and isomaltulose compared to the original recipe consisting only of simple sugars. The secondary objective is: -the assessment of the acceptability of all the fruit pastes tested (organoleptic, satiety and gastrointestinal comfort aspects).The study is composed of 7 visits Visit 1 – Selection Visit (Day -7) – Informed consent form – Clinical examination – Medical history – Anthropometric characteristics – Blood biochemical and hematological assessment – Compliance test with the original matrix will be carried out Visit 2 (D0) / Visit 3 (D7) / Visit 4 (D14) / Visit 5 (D21) / Visit 6 (D28): study period If all the biological criteria are respected, the subjects will have to come back to the clinical center for each of the 5 study periods. Volunteers will arrive fasted, without smoking in the morning. A catheter will be placed for blood sampling. After a first blood sampling for basal values, volunteers will ingest the equivalent of two bars of fruit pastes (about 80g in 10 minutes maximum) and blood will be withdrawn 15, 30, 45, 60, 90, 120 and 180 minutes after ingestion. The different matrices (5 in total) will be tested on the same volunteer. Plasma samples will be used to determine plasma glucose and fructose concentrations (aliquots stored in center for later assays) to evaluate the postprandial profiles of these two nutrients. At the end of the kinetic, the volunteers will be offered a complete meal. A satiety questionnaire will be performed before then 60 and 180 min after the ingestion of each fruit matrix. A questionnaire of satisfaction and acceptability will also be realized during the consumption of the matrix. After the 5 fruit matrix will be tested, the subject will be invited to participate in an individual interview of about 30-45min with a member of the project team. The purpose of this interview will be a qualitative approach to search for a food development that can could improve the sensory quality of the fruit pastes tested and intended for the elderly (see below). Visit 7 (D35 to D40): Participation in a discussion group (about 2 hours). During the participation in this group all 10 participants will be invited to taste the 5 products (original recipe, maltodextrin recipe, fructose recipe, isomaltulose recipe and mixed recipe comprising fructose and isomaltulose). Participants will be asked to indicate for each product their degree of appreciation for these products, their possible defects and qualities and to suggest ideas for improving their taste / texture / appearance. These interviews will alternate individual reflection phases and discussion phases according to the focus group method. Visit 7 will be the last visit of the study.

Interventions

  • Other: fruit paste matrice
    • Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

Arms, Groups and Cohorts

  • Experimental: Original recipe
    • Normal fruit paste
  • Experimental: maltodextrin recipe
    • fruit pastes in which some of the simple sugars in the recipe will be replaced by maltodextrin with a low glycemic index (DE12).
  • Experimental: fructose recipe
    • fruit pastes in which some of the simple sugars in the recipe (25% min) will be replaced by fructose
  • Experimental: isomaltulose recipe
    • fruit pastes with some of the sugars will be replaced (25% min) by isomaltulose
  • Experimental: mixed recipe
    • fruit pastes with some of the sugars will be replaced (25% min) by fructose / isomaltulose

Clinical Trial Outcome Measures

Primary Measures

  • Area Under the Curve (AUC) of glycemia
    • Time Frame: Day 0
    • Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of glycemia
    • Time Frame: Day 0
    • Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of glycemia
    • Time Frame: Day 0
    • Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of glycemia
    • Time Frame: Day 7
    • Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of glycemia
    • Time Frame: Day 7
    • Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of glycemia
    • Time Frame: day 7
    • Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of glycemia
    • Time Frame: day 14
    • Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of glycemia
    • Time Frame: day 14
    • Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of glycemia
    • Time Frame: day 14
    • Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of glycemia
    • Time Frame: day 21
    • Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of glycemia
    • Time Frame: day 21
    • Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of glycemia
    • Time Frame: day 21
    • Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of glycemia
    • Time Frame: day 28
    • Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of glycemia
    • Time Frame: day 28
    • Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of glycemia
    • Time Frame: day 28
    • Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Secondary Measures

  • Area Under the Curve (AUC) of fructose
    • Time Frame: Day 0
    • Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of fructose
    • Time Frame: Day 0
    • Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of fructose
    • Time Frame: Day 0
    • Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of fructose
    • Time Frame: Day 7
    • Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of fructose
    • Time Frame: Day 7
    • Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of fructose
    • Time Frame: Day 7
    • Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of fructose
    • Time Frame: Day 14
    • Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of fructose
    • Time Frame: Day 14
    • Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of fructose
    • Time Frame: Day 14
    • Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of fructose
    • Time Frame: Day 21
    • Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of fructose
    • Time Frame: Day 21
    • Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of fructose
    • Time Frame: Day 21
    • Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of fructose
    • Time Frame: Day 28
    • Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of fructose
    • Time Frame: Day 28
    • Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of fructose
    • Time Frame: Day 28
    • Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of glucagon
    • Time Frame: day 0
    • Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of glucagon
    • Time Frame: day 0
    • : Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of glucagon
    • Time Frame: day 0
    • Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of glucagon
    • Time Frame: day 7
    • Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of glucagon
    • Time Frame: day 7
    • Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of glucagon
    • Time Frame: Day 7
    • Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Area Under the Curve (AUC) of glucagon
    • Time Frame: Day 14
    • Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of glucagon
    • Time Frame: Day 14
    • Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of glucagon
    • Time Frame: Day 14
    • Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Area Under the Curve (AUC) of glucagon
    • Time Frame: Day 21
    • Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of glucagon
    • Time Frame: Day 21
    • Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of glucagon
    • Time Frame: Day 21
    • Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of glucagon
    • Time Frame: Day 28
    • Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of glucagon
    • Time Frame: Day 28
    • Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of glucagon
    • Time Frame: Day 28
    • Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of CCK
    • Time Frame: Day 0
    • Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of CCK
    • Time Frame: Day 0
    • Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of CCK
    • Time Frame: Day 0
    • Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of CCK
    • Time Frame: Day 7
    • Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of CCK
    • Time Frame: Day 7
    • Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of CCK
    • Time Frame: Day 7
    • Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of CCK
    • Time Frame: Day 14
    • Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of CCK
    • Time Frame: Day 14
    • Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of CCK
    • Time Frame: Day 14
    • Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of CCK
    • Time Frame: Day 21
    • Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of CCK
    • Time Frame: Day 21
    • Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of CCK
    • Time Frame: Day 21
    • Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of CCK
    • Time Frame: Day 28
    • Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of CCK
    • Time Frame: Day 28
    • Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of CCK
    • Time Frame: Day 28
    • Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of Grehlin
    • Time Frame: Day 0
    • Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of Grehlin
    • Time Frame: Day 0
    • Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of Grehlin
    • Time Frame: day 0
    • Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of Grehlin
    • Time Frame: day 7
    • Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of Grehlin
    • Time Frame: day 7
    • Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of Grehlin
    • Time Frame: day 7
    • Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Area Under the Curve (AUC) of Grehlin
    • Time Frame: day 14
    • Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of Grehlin
    • Time Frame: day 14
    • Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of Grehlin
    • Time Frame: day 14
    • Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of Grehlin
    • Time Frame: day 21
    • Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of Grehlin
    • Time Frame: day 21
    • Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of Grehlin
    • Time Frame: day 21
    • Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of Grehlin
    • Time Frame: day 28
    • Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of Grehlin
    • Time Frame: day 28
    • Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of Grehlin
    • Time Frame: day 28
    • Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of leptin
    • Time Frame: day 0
    • Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of leptin
    • Time Frame: day 0
    • Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of leptin
    • Time Frame: day 0
    • Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of leptin
    • Time Frame: day 7
    • Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of leptin
    • Time Frame: day 7
    • Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of leptin
    • Time Frame: day 7
    • Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste
  • Area Under the Curve (AUC) of leptin
    • Time Frame: day 14
    • Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of leptin
    • Time Frame: day 14
    • Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of leptin
    • Time Frame: day 14
    • Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste
  • Area Under the Curve (AUC) of leptin
    • Time Frame: day 21
    • Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of leptin
    • Time Frame: day 21
    • Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of leptin
    • Time Frame: day 21
    • Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of leptin
    • Time Frame: day 28
    • Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of leptin
    • Time Frame: day 28
    • Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of leptin
    • Time Frame: day 28
    • Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of GLP1
    • Time Frame: day 0
    • Area Under the Curve (AUC) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of GLP1
    • Time Frame: day 0
    • Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of GLP1
    • Time Frame: day 0
    • Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of GLP1
    • Time Frame: day 7
    • Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of GLP1
    • Time Frame: day 7
    • Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of GLP1
    • Time Frame: day 7
    • Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste
  • Area Under the Curve (AUC) of GLP1
    • Time Frame: day 14
    • Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of GLP1
    • Time Frame: day 14
    • Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of GLP1
    • Time Frame: day 14
    • Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of GLP1
    • Time Frame: day 21
    • Area Under the Curve (AUC) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of GLP1
    • Time Frame: day 21
    • Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of GLP1
    • Time Frame: day 21
    • Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of GLP1
    • Time Frame: day 28
    • Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of GLP1
    • Time Frame: day 28
    • Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of GLP1
    • Time Frame: day 28
    • Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of incretines
    • Time Frame: day 0
    • Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of incretines
    • Time Frame: day 0
    • Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of incretines
    • Time Frame: day 0
    • Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of incretines
    • Time Frame: day 7
    • Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of incretines
    • Time Frame: day 7
    • Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of incretines
    • Time Frame: day 7
    • Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of incretines
    • Time Frame: day 14
    • Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of incretines
    • Time Frame: day 14
    • Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of incretines
    • Time Frame: day 14
    • Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Area Under the Curve (AUC) of incretines
    • Time Frame: day 21
    • Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of incretines
    • Time Frame: day 21
    • Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of incretines
    • Time Frame: day 21
    • Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Area Under the Curve (AUC) of incretines
    • Time Frame: day 28
    • Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of incretines
    • Time Frame: day 28
    • Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of incretines
    • Time Frame: day 28
    • Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste
  • Area Under the Curve (AUC) of insulin
    • Time Frame: day 0
    • Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of insulin
    • Time Frame: day 0
    • Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of insulin
    • Time Frame: day 0
    • Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of insulin
    • Time Frame: day 7
    • Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of insulin
    • Time Frame: day 7
    • Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of insulin
    • Time Frame: day 7
    • Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of insulin
    • Time Frame: day 14
    • Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of insulin
    • Time Frame: day 14
    • Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of insulin
    • Time Frame: day 14
    • Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste
  • Area Under the Curve (AUC) of insulin
    • Time Frame: day 21
    • Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of insulin
    • Time Frame: day 21
    • Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of insulin
    • Time Frame: day 21
    • Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of insulin
    • Time Frame: day 28
    • Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of urea
    • Time Frame: day 28
    • Maximum Plasma Concentration (Cmax) of urea (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of insulin
    • Time Frame: day 28
    • Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of urea
    • Time Frame: day 0
    • Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of urea
    • Time Frame: day 0
    • Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of urea
    • Time Frame: day 0
    • Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of urea
    • Time Frame: day 7
    • Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of urea
    • Time Frame: day 7
    • Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of urea
    • Time Frame: day 7
    • Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of urea
    • Time Frame: day 14
    • Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Maximum Plasma Concentration (Cmax) of urea
    • Time Frame: day 14
    • Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of urea
    • Time Frame: day 14
    • Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of urea
    • Time Frame: day 21
    • Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of urea
    • Time Frame: day 21
    • Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste
  • Time of Maximum Plasma Concentration (Tmax) of urea
    • Time Frame: day 21
    • Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Area Under the Curve (AUC) of urea
    • Time Frame: day 28
    • Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste
  • Maximum Plasma Concentration (Cmax) of urea
    • Time Frame: day 28
    • Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
  • Time of Maximum Plasma Concentration (Tmax) of urea
    • Time Frame: day 28
    • Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste
  • Questionnaire of satiety
    • Time Frame: at time 0 after ingestion in Day 0
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry.
  • Questionnaire of satiety
    • Time Frame: at time 60 after ingestion in Day 0
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry
  • Questionnaire of satiety
    • Time Frame: at time 180 after ingestion in Day 0
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry.
  • Questionnaire of satiety
    • Time Frame: at time 0 after ingestion in Day 7
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry
  • Questionnaire of satiety
    • Time Frame: at time 60 after ingestion in Day 7
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry
  • Questionnaire of satiety
    • Time Frame: at time 180 after ingestion in Day 7
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry.
  • Questionnaire of satiety
    • Time Frame: at time 0 after ingestion in Day 14
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry.
  • Questionnaire of satiety
    • Time Frame: at time 60 after ingestion in Day 14
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry
  • Questionnaire of satiety
    • Time Frame: at time 180 after ingestion in Day 14
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry
  • Questionnaire of satiety
    • Time Frame: at time 0 after ingestion in Day 21
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry.
  • Questionnaire of satiety
    • Time Frame: at time 60 after ingestion in Day 21
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry.
  • Questionnaire of satiety
    • Time Frame: at time 180 after ingestion in Day 21
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry.
  • Questionnaire of satiety
    • Time Frame: at time 0 after ingestion in Day 28
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry.
  • Questionnaire of satiety
    • Time Frame: at time 60 after ingestion in Day 28
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry.
  • Questionnaire of satiety
    • Time Frame: at time 180 after ingestion in Day 28
    • Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where “0” means to be free from hunger and “10” to be very hungry.
  • Questionnaire of acceptability
    • Time Frame: day 0
    • Acceptability was assessed by a 7-point time scale where “1” means a very poor acceptability and “7” means a very good acceptability
  • Questionnaire of acceptability
    • Time Frame: day 7
    • Acceptability was assessed by a 7-point time scale where “1” means a very poor acceptability and “7” means a very good acceptability
  • Questionnaire of acceptability
    • Time Frame: day 14
    • Acceptability was assessed by a 7-point time scale where “1” means a very poor acceptability and “7” means a very good acceptability
  • Questionnaire of acceptability
    • Time Frame: day 21
    • Acceptability was assessed by a 7-point time scale where “1” means a very poor acceptability and “7” means a very good acceptability
  • Questionnaire of acceptability
    • Time Frame: day 28
    • Acceptability was assessed by a 7-point time scale where “1” means a very poor acceptability and “7” means a very good acceptability
  • Facilited individual interview
    • Time Frame: day 40
    • Facilitated interview to assess organoleptic, satiety and gastrointestinal comfort
  • Focus group
    • Time Frame: day 40
    • Focus group interview to assess organoleptic, satiety and gastrointestinal comfort

Participating in This Clinical Trial

Inclusion Criteria

  • Male subject – Subject over 65 years (included) – Subject over 61 kg (included) – Able to consume the 80g of fruit pastes in 10 minutes – Subject with a dentition consistent with the fruit paste consumption in 10 minutes – Subject with a Body Mass Index (BMI) between 21 and 30 kg/m2 – Subject agreeing to provide written consent Exclusion Criteria:

  • Subject with acute pathology (unstable or terminal pathology, severe dementia) – Subject with renal failure (clearance < 60 ml/min) – Subject with metabolic syndrome (3 of the following 5 criteria: waist greater than 94 cm, blood triglyceride greater than 1.7 mmol/l, blood pressure greater than or equal to 130 mm Hg/85 mm Hg, cholesterol (HDL) less than 1.0 mmol/l in men, blood glucose greater than or equal to 5.6 mmol/l) – Person with diabetes – Subject on food restriction – Subject undergoing chemotherapy – Subject with gastrointestinal pathology – Subject in a diet incompatible with the nutritional protocol (gluten, lactose or milk intolerance, vegan)

Gender Eligibility: Male

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Collaborator
    • Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gisèle Pickering, Principal Investigator, University Hospital, Clermont-Ferrand

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