Inulin-type Fructans-rich Vegetables, Obesity, Gut Microbiota

Overview

The purpose of the study was to evaluate the effect of a diet based on ITF-rich vegetables in combination with purified ITF supplementation on weight management, metabolic alteration and gut microbiota composition. Obese patients were treated for 3 months and several parameters were measured before and after the study period.

Full Title of Study: “Impact of a Diet Rich in Inulin-type Fructans Combined With Inulin Supplementation on Gut Microbiota Composition and Metabolic Parameters in Obese Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 2018

Interventions

  • Dietary Supplement: Inulin
    • Patient receive inulin as dietary supplement (16g/d) in combination with dietary advice to restrict caloric intake and to enhance the consumption of inulin-rich vegetables
  • Dietary Supplement: Placebo
    • Patient receive maltodextrin as dietary supplement (16g/d) in combination with dietary advice to restrict caloric intake and to enhance the consumption of vegetables poor in inulin

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • 16 g maltodextrin/day + recipes based on vegetables poor in inulin-type fructans
  • Experimental: Inulin
    • 16 g inulin/day + recipes based on vegetables rich in inulin-type fructans

Clinical Trial Outcome Measures

Primary Measures

  • Gut microbiota composition
    • Time Frame: Month 0 – Month 3
    • Relative abundance (percent) of bacterial taxa will be assessed by 16S rRNA gene sequencing

Secondary Measures

  • Anthropometry
    • Time Frame: Month 0 – Month 3
    • height (cm)
  • Anthropometry
    • Time Frame: Month 0 – Month 3
    • weight (kg)
  • Anthropometry
    • Time Frame: Month 0 – Month 3
    • hip circumference and waist circumference (cm)
  • Anthropometry
    • Time Frame: Month 0 – Month 3
    • Body mass index (BMI, kg/m2)
  • Anthropometry
    • Time Frame: Month 0 – Month 3
    • Body composition by bioimpedance analysis (fat mass, fat free mass, kg)
  • Anthropometry
    • Time Frame: Month 0 – Month 3
    • Body composition by CT scan analysis (fat and muscle areas, cm2)
  • Blood pressure
    • Time Frame: Month 0 – Month 3
    • systolic and diastolic blood pressures (mm Hg)
  • Glucose homeostasis
    • Time Frame: Month 0 – Month 3
    • glycemia (mg/dl) (fasted, after an oral glucose tolerance test)
  • Glucose homeostasis
    • Time Frame: Month 0 – Month 3
    • insulinemia (mU/l) (fasted, after an oral glucose tolerance test)
  • Glucose homeostasis
    • Time Frame: Month 0 – Month 3
    • C-peptide (pM)
  • Glucose homeostasis
    • Time Frame: Month 0 – Month 3
    • glycated hemoglobin HbA1c (percent)
  • Glucose homeostasis
    • Time Frame: Month 0 – Month 3
    • dipeptidyl-peptidase IV activity in the plasma (UI/l)
  • Lipid homeostasis
    • Time Frame: Month 0 – Month 3
    • HLD-Cholesterol, triglycerides, total cholesterol, free fatty acids in the plasma (mg/dl)
  • Hepatic fibrosis and/or steatosis
    • Time Frame: Month 0 – Month 3
    • hepatic enzymes in the plasma (AST, ALT, gamma-glutamyl transpeptidase, U/l)
  • Hepatic fibrosis and/or steatosis
    • Time Frame: Month 0 – Month 3
    • Elasticity by Fibroscan (kPa)
  • Hepatic fibrosis and/or steatosis
    • Time Frame: Month 0 – Month 3
    • controlled attenuation parameter (CAP) by Fibroscan (dB/m)
  • Eating behavior
    • Time Frame: Month 0 – Month 3
    • Questionnaire for Eating Disorders Diagnosis (Q-EDD). The Q-EDD is a 50-items questionnaire based on Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV allowing the psychologist to diagnose eating disorders (anorexia nervosa, bulimia, binge eating), there is no quantitative result.
  • Eating behavior
    • Time Frame: Month 0 – Month 3
    • Dutch Eating Behaviour Questionnaire (DEBQ).The DEBQ is a 33-items questionnaire assessing 3 distinct behaviour: emotional eating (13 items), external eating (10 items) and restrained eating (10 items). Each item is rated on a 5-point scale. A high score is observed when individual tended to eat more when submitted to emotional and external stimuli (for emotional and external eating subscales) or when he displayed elevated cognitive control on its eating behaviour (for the restrained eating subscale).
  • Mood and emotional competence
    • Time Frame: Month 0 – Month 3
    • Positive and Negative Affect Schedule (PANAS, two subscale – positive and negative – from 10 to 50, higher score associated with higher positive and negative emotion respectively)
  • Mood and emotional competence
    • Time Frame: Month 0 – Month 3
    • Scale of Positive and Negative Experience (SPANE, two subscale – positive and negative – from 6 to 30, higher score associated with higher positive and negative emotion respectively)
  • Mood and emotional competence
    • Time Frame: Month 0 – Month 3
    • Profile of Emotional Competence (PEC, from 0 to 5, higher score associated with better emotional competence).
  • Cognition
    • Time Frame: Month 0 – Month 3
    • computer-based tests of the flexibility, the working memory and the inhibition of participants. The measurements will be the time to complete the task on the computer as well as the number of errors.
  • Dietary intake
    • Time Frame: Month 0 – Month 3
    • one-week recall questionnaire to evaluate the dietary intake (macronutrients, caloric intake)
  • Biomarkers of systemic inflammation
    • Time Frame: Month 0 – Month 3
    • Cytokines levels (Il-1β; IL-8; IL-12p70; IL-17a; MCP1; TNFα; IFNγ) by multiplex immunoassay (all in pg/ml)
  • Gut peptides
    • Time Frame: Month 0 – Month 3
    • Gut peptide (GLP-1, GIP, ghrelin, PP, leptin) multiplex immunoassay (all in pg/ml)
  • Metabolomics
    • Time Frame: Month 0 – Month 3
    • metabolomic analysis of biological samples (urine, blood and/or stool)
  • Physical activity
    • Time Frame: Month 0 – Month 3
    • IPAQ questionnaire (The IPAQ long form asks details about the specific types of activities undertaken within the four main domains (leisure time PA, domestic and gardening (yard) activities, work-related PA and transport-related PA). Computation of the total scores for the long form requires summation of the duration (in minutes) and frequency (days) for all the types of activities in all domains. Results allowed us to classify different levels of PA proposed by the questionnaire (total, low-moderate or high-intensity physical activities)

Participating in This Clinical Trial

Inclusion Criteria

  • Body mass index > 30 kg/m² – Caucasian – Presence of at least one of the following comorbidity : prediabetes, diabetes, dyslipidemia, hypertension, steatosis. Exclusion Criteria:

  • Psychiatric problems or use of antipsychotic – Consumption of antibiotics, pro/prebiotics, fibre dietary supplement, or any molecules that modifies the intestinal transit (<6 weeks) – Pregnancy in progress or planified within 6 months – Specific dietary practise (vegetarian, vegan,…) – Specific dietary treatment (<6 weeks) (e.g. high protein diet) – Type 1 diabetes – Excessive alcohol consumption (>3 glasses/day) – Inconclusive acceptability test (regarding the protocol of the intervention and the vegetables used in the protocol)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean-Paul Thissen, Pr., Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Citations Reporting on Results

Hiel S, Gianfrancesco MA, Rodriguez J, Portheault D, Leyrolle Q, Bindels LB, Gomes da Silveira Cauduro C, Mulders MDGH, Zamariola G, Azzi AS, Kalala G, Pachikian BD, Amadieu C, Neyrinck AM, Loumaye A, Cani PD, Lanthier N, Trefois P, Klein O, Luminet O, Bindelle J, Paquot N, Cnop M, Thissen JP, Delzenne NM. Link between gut microbiota and health outcomes in inulin -treated obese patients: Lessons from the Food4Gut multicenter randomized placebo-controlled trial. Clin Nutr. 2020 Dec;39(12):3618-3628. doi: 10.1016/j.clnu.2020.04.005. Epub 2020 Apr 13.

Leyrolle Q, Cserjesi R, Mulders MDGH, Zamariola G, Hiel S, Gianfrancesco MA, Rodriguez J, Portheault D, Amadieu C, Leclercq S, Bindels LB, Neyrinck AM, Cani PD, Karkkainen O, Hanhineva K, Lanthier N, Trefois P, Paquot N, Cnop M, Thissen JP, Klein O, Luminet O, Delzenne NM. Specific gut microbial, biological, and psychiatric profiling related to binge eating disorders: A cross-sectional study in obese patients. Clin Nutr. 2021 Apr;40(4):2035-2044. doi: 10.1016/j.clnu.2020.09.025. Epub 2020 Sep 28.

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