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

Tereos66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Pre Diabetes Prediabetic State Dysglycemia PreDiabetes

Interventions

Non digestible carbohydratesDIETARY_SUPPLEMENT

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.

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (3)

IPL

Lille, France

Biofortis Center Paris

Paris, France

UIC BIOFORTIS Saint-Herblain

Saint-Herblain, France

Outcomes

Primary Outcomes

Glycated hemoglobin

Change from baseline of Hba1c level (%)

Time frame: V2 (randomization) and V5 (12 weeks of intervention)