Study to Assess the Effects of Non Digestible Carbohydrates on Long-Term Glucose Homeostasis in Untreated Prediabetic Subjects (FOS_GLUCOSE)

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

This clinical study aims to prove that the efficacy of non digestible carbohydrates 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.

Study Overview

• Status: Active, not recruiting
• Conditions: PreDiabetes; Prediabetic State; Pre Diabetes; Dysglycemia
• Intervention / Treatment: Dietary supplement: Non digestible carbohydrates; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion LIGNER; Phone Number: 0240205799; Email: marion.ligner@mxns.com
• Study Contact Backup: Name: Biofortis Nutrisciences; Phone Number: 0240205799; Email: fosglucose-study_oc@mxns.com

Study Locations

• France
  • Lille, France
    • IPL
  • Paris, France, 75012
    • Biofortis Center Paris
  • Saint-Herblain, France
    • UIC BIOFORTIS Saint-Herblain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 65 years (limits included);
• BMI between 23 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);
• Smoking maximum 10 cigarettes per week or equivalent 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test product; Food ingredient containing non digestible carbohydrates, in shape of powder	Dietary supplement: Non digestible carbohydrates; 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.
Placebo Comparator: Placebo; Food ingredient containing containing 95% of maltodextrin	Dietary supplement: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated hemoglobin	Absolute variations of Hba1c level (%)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Fasting glycemia	Change from baseline of fasting glycemia (g/L)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Fasting insulinemia	Change from baseline of fasting insulinemia (mU/L)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Fructosamine	Change from baseline of fructosamine (μmol/L)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Insulin indexes	Change from baseline of HOMA-IR (Homeostasis Model Assessment of Insulin) and QUICKI (Quantitative Insulin sensitivity Check Index) indices	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Insulin sensitivity index	Change from baseline of insulin sensitivity index (ISI)	V2 (randomization) and V5 (12 weeks of intervention)
Glycemia level	Change from baseline of glycemia level (g/L)	V2 (randomization) and V5 (12 weeks of intervention)
Incremental Area Under the Curve (iAUC) of glycemia	Change from baseline of iAUC of glycemia (g/L)	V2 (randomization) and V5 (12 weeks of intervention)
Insulinemia	Change from baseline of insulinemia levels (mU/L)	V2 (randomization) and V5 (12 weeks of intervention)
Incremental Area Under the Curve (iAUC) of insulinemia	Change from baseline of iAUC of insulinemia (mU/L)	V2 (randomization) and V5 (12 weeks of intervention)
Glucacon-like Peptide 1 (GLP-1)	Change from baseline of GLP-1 levels (pmol/L)	V2 (randomization) and V5 (12 weeks of intervention)
Bone mineral composition	Change from baseline of bone mineral composition (kg)	V2 (randomization) and V5 (12 weeks of intervention)
Total lean mass	Change from baseline of total lean mass (g and %)	V2 (randomization) and V5 (12 weeks of intervention)
Total fat mass	Change from baseline of total fat mass (g and %)	V2 (randomization) and V5 (12 weeks of intervention)
Bone Mineral Density	Change from baseline of bone mineral density (g/cm2)	V2 (randomization) and V5 (12 weeks of intervention)
Total Body Mass	Change from baseline of total body mass (kg)	V2 (randomization) and V5 (12 weeks of intervention)
Weight	Change from baseline of weight (in kg)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Body Mass Index (BMI)	Change from baseline of BMI (in kg/m2)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Waist and Hip measurement	Change from baseline of waist and hip Circumference (in cm)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Anthropometric ratios	Change from baseline of Waist to Hip ratio and Waist to Height ratio	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Satiety and Appetite sensation	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	V2 (randomization) and V5 (12 weeks of intervention)
Total energy intake	Change from baseline of total energy intake - TEI (kcal/day)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Energy intake	Change from baseline of percentage of energy intake from fat, carbohydrates and protein (g and %TEI)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Fiber intake	Change from baseline of percentage of percentage of fiber (g)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Alcohol intake	Change from baseline of percentage of percentage of alcohol intake (absolute quantities, g/day)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Biomarker of inflammation	Change from baseline of high-sensitivity C-reactive Protein (CRPhs) (mg/L)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Intestinal microbiota composition	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)	V2 (randomization) and V5 (12 weeks of intervention)
Fecal Short-Chain Fatty Acids (SCFA)	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)	V2 (randomization) and V5 (12 weeks of intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)	Number of adverse events (including gastro-intestinal symptoms) by subject that appeared during the entire duration of the study	V1 (Inclusion), V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Heart Rate (HR)	Change from baseline of HR (bpm)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Blood pressure	Change from baseline of Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)	V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)

Collaborators and Investigators

• Sponsor: Tereos
• Collaborators: BioFortis

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: PEC19095; 2020-A02304-35 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No