Study to Assess the Effects of Non Digestible Carbohydrates 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.


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.