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

NCT ID: NCT04767672

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-05
• Study Completion Date: 2024-03-31

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.

Conditions

Pre Diabetes; Prediabetic State; Dysglycemia; PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Test product

Food ingredient containing non digestible carbohydrates, in shape of powder

Group Type: EXPERIMENTAL

Non digestible carbohydrates

Intervention Type: DIETARY_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.

Placebo

Food ingredient containing containing 95% of maltodextrin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_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.

Interventions

Non digestible carbohydrates

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioFortis

OTHER

Sponsor Role: collaborator

Tereos

INDUSTRY

Sponsor Role: lead

Responsible Party

Isabelle Metreau

Coordinating investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IPL

Lille, , France

Biofortis Center Paris

Paris, , France

UIC BIOFORTIS Saint-Herblain

Saint-Herblain, , France

Countries

France

Other Identifiers

2020-A02304-35

Identifier Type: OTHER

Identifier Source: secondary_id

PEC19095

Identifier Type: -

Identifier Source: org_study_id