Actively Recruiting
Impact of Starch Digestibility on Glycemic Variability and Control, Cardiometabolic and Inflammatory Profiles, Microbiota and Intestinal Health in Subjects With Insulin Resistance
Led by Mondelēz International, Inc. · Updated on 2026-02-13
40
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
M
Mondelēz International, Inc.
Lead Sponsor
C
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Collaborating Sponsor
AI-Summary
What this Trial Is About
To study the potential impact of a diet rich in both Slowly Digestible Starch (SDS) and Resistant Starch (RS), we propose a 2-month nutritional intervention study in which we will study the evolution of carbohydrate variability and metabolism and health-related parameters in 40 volunteers with insulin resistance. Regular sampling of blood, urine and faeces as well as continuous measurement of blood glucose levels will be performed to assess changes in blood glucose levels, insulin resistance, lipid metabolism, inflammation and the composition of the microbiota following the introduction of starch products rich in SDS and RS into the diet.
CONDITIONS
Official Title
Impact of Starch Digestibility on Glycemic Variability and Control, Cardiometabolic and Inflammatory Profiles, Microbiota and Intestinal Health in Subjects With Insulin Resistance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years (inclusive)
- HOMA-IR value of 2.5 or higher
- Body Mass Index (BMI) between 25 and 40 kg/m² (inclusive)
- Stable weight in the past 3 months within +/- 5% of body weight
- Waist circumference over 80 cm for women and over 94 cm for men
- Sedentary or regular stable physical activity up to 4 hours per week
- Ability to understand study information and provide informed consent
- Ability to read and write in French
- Having a freezer and comfortable storing stool samples at home
- Completed a prior medical exam during screening
- Willingness to modify diet for 2 months
- No food intolerances or allergies
- Regularly consuming the study products
- Fiber intake of 25 grams per day or less
- Willing to eat three main meals and no more than one snack daily, with at least two hours between meals or snacks
You will not qualify if you...
- Under legal protection such as guardianship or curatorship
- Unstable medical or psychological conditions affecting study compliance or safety
- Conditions interfering with study evaluations as judged by investigator
- Deprived of liberty by judicial or administrative decision
- Failure to comply with exclusion periods from other studies
- Smoking or vaping more than 5 cigarettes per day and unable to abstain during study visits
- Alcohol abuse exceeding 30 grams per day or more than three drinks daily
- Not covered by social security or similar system
- Lack of valid health certificates during epidemic situations
- Fasting blood glucose 7 mmol/L or higher
- Triglycerides above 4 g/L
- LDL-cholesterol above 1.90 g/L
- Estimated glomerular filtration rate below 60 ml/min
- Other clinically significant biological abnormalities
- Specific diets such as vegetarian, vegan, high-protein, or low-carbohydrate
- Regular use of dietary supplements like prebiotics or probiotics before and during study
- Blood donation within 2 months prior to selection
- Claustrophobia preventing required measurements
- Difficult venous access for blood sampling
- Type 1 or Type 2 diabetes
- High blood pressure or hypertension treatment
- Endocrine diseases affecting carbohydrate metabolism
- Gastrointestinal diseases with inflammation or malabsorption
- History of bloody diarrhea, pancreatic insufficiency, bariatric or digestive surgery (except minor cases)
- Severe eating disorders
- Liver failure
- Immunosuppression from various causes
- Central venous catheter or recent surgery
- Other unstable or untreated significant health abnormalities
- Use of obesity medications within past 3 months or during study
- Recent antibiotic or laxative use affecting gut microbiota
- Use of treatments interfering with study measures
- Pregnancy, breastfeeding, or planning pregnancy
- Known allergy to adhesive materials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centre de Recherche en Nutrition Humaine Rhone-Alpes
Lyon, France, 69310
Actively Recruiting
Research Team
J
Julie-Anne Nazare, PhD
CONTACT
A
Alexandra Meynier, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here