Clinical trial NCT04767672: Study to Assess the Effects of Non Digestible Carbohydrates on Long-Term Glucose Homeostasis in Untreated Prediabetic Subjects
Official title: 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: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pre Diabetes
Prediabetic State
Dysglycemia
PreDiabetes
Lead sponsor: Tereos
Sponsor class: INDUSTRY
Collaborators: name: BioFortis
First posted: 2021-02-23
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicentre randomized, parallel arms, double-blind, placebo-controlled clinical trial
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
Secondary outcomes:
measure: Glycated hemoglobin
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Fasting glycemia
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Fasting insulinemia
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Fructosamine
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Insulin indexes
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Insulin sensitivity index
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
measure: Glycemia level
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
measure: Incremental Area Under the Curve (iAUC) of glycemia
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
measure: Insulinemia
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
measure: Incremental Area Under the Curve (iAUC) of insulinemia
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
measure: Glucacon-like Peptide 1 (GLP-1)
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
measure: Bone mineral composition
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
measure: Total lean mass
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
measure: Total fat mass
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
measure: Bone Mineral Density
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
measure: Total Body Mass
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
measure: Weight
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Body Mass Index (BMI)
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Waist and Hip measurement
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Anthropometric ratios
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Satiety and Appetite sensation
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
measure: Total energy intake
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Energy intake
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Fiber intake
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Alcohol intake
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Biomarker of inflammation
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Intestinal microbiota composition
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
measure: Fecal Short-Chain Fatty Acids (SCFA)
timeFrame: V2 (randomization) and V5 (12 weeks of intervention)
Other outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: V1 (Inclusion), V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Heart Rate (HR)
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
measure: Blood pressure
timeFrame: V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)
Locations:
city: Lille
country: France
facility: IPL
city: Paris
country: France
facility: Biofortis Center Paris
city: Saint-Herblain
country: France
facility: UIC BIOFORTIS Saint-Herblain
Study officials:
References: