Study to Assess the Effects of Short-Chain Fructo-Oligosaccharides on Long-Term Glucose Homeostasis in Untreated Prediabetic Subjects

Overview

This clinical study aims to prove that the efficacy of short-chain fructo-oligosaccharides (scFOS) supplementation (daily dose of 20 grams consumed twice a day for 12 weeks) on the regulation of glucose homeostasis is superior than placebo in prediabetic subjects.

Full Title of Study: “Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Effects of Short-Chain Fructo-Oligosaccharides on Long-Term Glucose Homeostasis in Untreated Prediabetic Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2023

Interventions

  • Dietary Supplement: ACTILIGHT® 950P
    • the subjects will consume 2 bags of 10 grams per day of the product: 1 bag in the morning and 1 bag at lunch or in the evening, at the beginning of the meal, diluted in a large glass of beverage, during 12 weeks.
  • Dietary Supplement: MALDEX G120®
    • the subjects will consume 2 bags of 10 grams per day of the product: 1 bag in the morning and 1 bag at lunch or in the evening, at the beginning of the meal, diluted in a large glass of beverage, during 12 weeks.

Arms, Groups and Cohorts

  • Experimental: Test product
    • ACTILIGHT® 950P (scFOS: short chain fructo-oligosaccharides) is a food ingredient containing 95% of scFOS, in shape of powder
  • Placebo Comparator: Placebo
    • MALDEX G120® is a food ingredient containing containing 95% of maltodextrin

Clinical Trial Outcome Measures

Primary Measures

  • Glycated hemoglobin
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline of Hba1c level (%)

Secondary Measures

  • Glycated hemoglobin
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Absolute variations of Hba1c level (%)
  • Fasting glycemia
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Change from baseline of fasting glycemia (g/L)
  • Fasting insulinemia
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Change from baseline of fasting insulinemia (mU/L)
  • Fructosamine
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Change from baseline of fructosamine (μmol/L)
  • Insulin indexes
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Change from baseline of HOMA-IR (Homeostasis Model Assessment of Insulin) and QUICKI (Quantitative Insulin sensitivity Check Index) indices
  • Insulin sensitivity index
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline of insulin sensitivity index (ISI)
  • Glycemia level
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline of glycemia level (g/L)
  • Incremental Area Under the Curve (iAUC) of glycemia
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline of iAUC of glycemia (g/L)
  • Insulinemia
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline of insulinemia levels (mU/L)
  • Incremental Area Under the Curve (iAUC) of insulinemia
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline of iAUC of insulinemia (mU/L)
  • Glucacon-like Peptide 1 (GLP-1)
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline of GLP-1 levels (pmol/L)
  • Bone mineral composition
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline of bone mineral composition (kg)
  • Total lean mass
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline of total lean mass (g and %)
  • Total fat mass
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline of total fat mass (g and %)
  • Bone Mineral Density
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline of bone mineral density (g/cm2)
  • Total Body Mass
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline of total body mass (kg)
  • Weight
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Change from baseline of weight (in kg)
  • Body Mass Index (BMI)
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Change from baseline of BMI (in kg/m2)
  • Waist and Hip measurement
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Change from baseline of waist and hip Circumference (in cm)
  • Anthropometric ratios
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Change from baseline of Waist to Hip ratio and Waist to Height ratio
  • Satiety and Appetite sensation
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change on satiety and appetite sensation using 100-mm VAS to complete 15 min before the meal, 30 min, 60 min, 120 min, 180 min and 240 min after the meal at which study product was consumed
  • Total energy intake
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Change from baseline of total energy intake – TEI (kcal/day)
  • Energy intake
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Change from baseline of percentage of energy intake from fat, carbohydrates and protein (g and %TEI)
  • Fiber intake
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Change from baseline of percentage of percentage of fiber (g)
  • Alcohol intake
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Change from baseline of percentage of percentage of alcohol intake (absolute quantities, g/day)
  • Biomarker of inflammation
    • Time Frame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
    • Change from baseline of high-sensitivity C-reactive Protein (CRPhs) (mg/L)
  • Intestinal microbiota composition
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline microbiota composition for alpha-diversity indices (Shannon and Chao indices) and abundances at the phylum, family and genus level assessed by 16S metabarcoding (in a subgroup of 30 subjects only)
  • Fecal Short-Chain Fatty Acids (SCFA)
    • Time Frame: V2 (randomization) and V5 (12 weeks of intervention)
    • Change from baseline of fermentative activity of the intestinal microbiota assessed by measuring short-chain fatty acids concentrations in stool (in the same subgroup of 30 subjects only)

Participating in This Clinical Trial

Inclusion Criteria

  • Age between 18 and 65 years (limits included); – BMI between 25 and 34.9 kg/m² (limits included); – Dysglycemic or prediabetic subjects with no antidiabetic medication (medical or lifestyle (hygiene-dietetic measures or specific regimen treatment); – Consuming 10 to 20 g quantity of fiber per day (based on the 3-days food diary fulfilled by the subject between V1 and V2 visits); – Non smoking subject and agreeing to keep this habit unchanged throughout the study; – Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form; – Affiliated with a social security scheme; – Agree to be registered on the volunteers in biomedical research file; – Fasting venous glycemia ≥ 1 g/L and ≤ 1.25 g/L at V1 visit. Exclusion Criteria:

  • Metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder; – Severe chronic disease or Intestinal Bowel Syndrome (IBS) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator; – History of retinopathy, microalbuminuria, ischemic cardiovascular event in the 6 months before the study; – Known or a suspected food allergy or intolerance orhypersensitivity to any food ingredient; – Known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient; – Pregnant or lactating women or intending to become pregnant within 4 months ahead; – Women starting hormone replacement therapy or oral contraception (treatment must be stable for at least 3 months); – History of bariatric surgery; – History of any surgery in the 3 months before V1 visit or having scheduled any surgery within 4 months ahead; – Under dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the V1 visit (< 3 months); – Under treatment which could significantly affect parameter(s) followed during the study according to the investigator or stopped less than 3 months before the V1 visit; – Under antibiotic treatment in the 3 to 6 months before V1 visit, depending on the antibiotic consumed and according to the investigator; – Significant change in food habits or in physical activity in the 3 months before V1 visit or not agreeing to keep them unchanged throughout the study; – Current or planned in the next 4 months specific diet (hyper or hypocaloric, vegan, vegetarian…) or stopped less than 3 months before the study; – Personal history of anorexia nervosa, bulimia or significant eatingdisorders according to the investigator; – Consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 daily for women or not agreeing to keep his alcohol consumption habits unchanged throughout the study; – Taking part in another clinical trial or being in the exclusion period of a previous clinical trial; – Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros; – Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision; – Psychological or linguistic incapability to sign the informed consent; – Impossible to contact in case of emergency. – Fasting blood triglycerides > 3,5 g/L; – Fasting blood of total cholesterol > 4,5 g/L or HDLc < 0,1 g/L with an abnormality judged as clinically significant according to the investigator; – Blood ASAT, ALAT or GGT > 3 times ULN (laboratory Upper Limit of Normal); – Blood urea > 12 mmol/L or creatinine > 125 μmol/L; – Complete Blood Count (CBC) with hemoglobin < 11 g/L or leucocytes < 3000/mm3 or leucocytes > 16000/mm3.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tereos
  • Collaborator
    • Biofortis, Merieux NutriSciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Isabelle Metreau, Coordinating investigator – Tereos
  • Overall Contact(s)
    • N’deye SECK, 0240205799, ndeye.seck@mxns.com

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