study to assess the effects of non digestible carbohydrates on long-term glucose homeostasis in untreated prediabetic subjects

Conditions: Pre Diabetes; Prediabetic State; Dysglycemia; PreDiabetes

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 \ 16000/mm3.