Status:
UNKNOWN
Study to Assess the Effects of Non Digestible Carbohydrates on Long-Term Glucose Homeostasis in Untreated Prediabetic Subjects
Lead Sponsor:
Tereos
Collaborating Sponsors:
BioFortis
Conditions:
Pre Diabetes
Prediabetic State
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04767672
Start Date
May 5 2021
End Date
March 1 2024
Last Update
January 3 2024
Active Locations (3)
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1
IPL
Lille, France
2
Biofortis Center Paris
Paris, France, 75012
3
UIC BIOFORTIS Saint-Herblain
Saint-Herblain, France