Impact of Starch Digestibility on Glycemic Variability and Control, Cardiometabolic and Inflammatory Profiles, Microbiota and Intestinal Health in Subjects With Insulin Resistance

Recruiting now · Not applicable

Conditions studied: Insulin Resistance

In brief

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.

Key facts

Study ID: NCT07408479
Run by: Mondelēz International, Inc.
People needed: 40
Starts: 2025-11-15
Expected to finish: 2028-07-01
Last updated by the study team: 2026-02-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

General criteria:
Age between 18 and 75 years (bounds included)
HOMA-IR ≥ 2.5
Body Mass Index (BMI) between 25 and 40 kg/m² (bounds included)
Stable weight over the past 3 months (+/- 5% of body weight)
Waist circumference > 80 cm for women, > 94 cm for men
Sedentary subject or subject practising regular and stable physical activity for the duration of the study (maximum 4 hours per week)
Able to understand the provided information and having signed the informed consent forms
Able to read and write in French
Having a freezer and comfortable with storing stool samples at home
Having undergone a prior medical examination during the screening visit
Food-related criteria:
Willing to modify their diet for 2 months
No food intolerances or allergies
Regular consumption of the study products
Fiber intake ≤ 25 g/day
Willing to consume three main meals with no more than one snack per day and to take meals or snacks at least two hours apart

You may not qualify if…

General criteria:
Adult under legal protection (guardianship or curatorship)
Person with unstable medical or psychological conditions that, according to the investigator, could lead to non-compliance or non-cooperation during the study or compromise safety or participation (as per Articles L.1121-6, L.1121-8, L.1121-9, and L.1122-1-2 of the French Public Health Code)
Presence of a condition identified during clinical examination or medical interview that could interfere with study evaluations, as judged by the investigator
Person deprived of liberty by judicial or administrative decision
Failure to comply with the exclusion period of another study as indicated in the "national volunteer database"
Person exceeding the annual compensation limit for participation in research protocols
Tobacco (or vaping equivalent) consumption > 5 cigarettes per day and inability to abstain from smoking or vaping from the evening prior to exploration days specified in the protocol
Alcoholism or alcohol abuse (> 30 g/day). Consuming more than three alcoholic drinks per day is considered abusive. One alcoholic drink corresponds to 30 mL of spirits, 120 mL of wine, or 330 mL of beer or abuse or dependency on another drug
Person not affiliated with a social security system or benefiting from a similar scheme
Absence of valid, approved health certificates in the event of government measures during an exceptional epidemic situation
Biological criteria:
Fasting blood glucose ≥ 7 mmol/L or ≥ 1.26 g/L
Triglycerides > 4 g/L
LDL-cholesterol > 1.90 g/L
eGRF (estimated glomerular filtration rate) < 60 ml/min
Other biological abnormality with significant clinical relevance according to the investigator
Population-related criteria :
Person with a specific dietary regimen (vegetarian, lacto-vegetarian, vegan, high-protein, low-carbohydrates, weight-loss diet, etc.)
Person consuming dietary supplements (prebiotics, probiotics, or minerals such as divalent cations like magnesium and calcium) regularly in the month before the selection visit and during the study
Blood donation within 2 months prior to the selection visit
Claustrophobia preventing indirect calorimetry measurement
Limited venous access making blood sampling and catheter placement difficult
Therapeutic and medical criteria:
Type 1 or Type 2 diabetes

Where it is running

Centre de Recherche en Nutrition Humaine Rhone-Alpes — Lyon, France (enrolling)

Full record on ClinicalTrials.gov

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