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

NCT04767672 | Unknown

• 2 other identifiers: PEC190952020-A02304-35
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin

  Change from baseline of Hba1c level (%)

  V2 (randomization) and V5 (12 weeks of intervention)

Secondary Outcomes (28)

• Glycated hemoglobin

  V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)

• Fasting glycemia

  V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)

• Fasting insulinemia

  V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)

• Fructosamine

  V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)

• Insulin indexes

  V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)

Other Outcomes (3)

• Incidence of adverse events (AEs)

  V1 (Inclusion), V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)

• Heart Rate (HR)

  V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)

• Blood pressure

  V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention)

Study Arms (2)

Test product

EXPERIMENTAL

Food ingredient containing non digestible carbohydrates, in shape of powder

Dietary Supplement: Non digestible carbohydrates

Placebo

PLACEBO COMPARATOR

Food ingredient containing containing 95% of maltodextrin

Dietary Supplement: Placebo

Interventions

Non digestible carbohydrates 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.

Test product

Placebo 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tereos: lead
• BioFortis: collaborator

Study Sites (3)

IPL

Lille, France

Location

Biofortis Center Paris

Paris, 75012, France

Location

UIC BIOFORTIS Saint-Herblain

Saint-Herblain, France

Location

Related Publications (1)

• Le Bourgot C, Capronnier O, Graf S, Carton T. Targeting gut microbiota with short-chain fructo-oligosaccharides prebiotic fibers to support metabolic health in overweight prediabetic adults: a randomized, double-blinded, placebo-controlled study. Front Nutr. 2025 Dec 17;12:1718169. doi: 10.3389/fnut.2025.1718169. eCollection 2025.

  PMID: 41479657 DERIVED

MeSH Terms

Conditions

Glucose Intolerance; Prediabetic State

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating investigator

Model Details: multicentre randomized, parallel arms, double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 23, 2021
• Study Start: May 5, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)