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

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.

NCT Number	NCT07408479
Lead Sponsor	Mondelēz International, Inc. Collaborators: Centre de Recherche en Nutrition Humaine Rhone-Alpe, Unite MetaGenoPolis INRAE
Conditions	Insulin Resistance
Enrollment	40 participants
Start Date	2025-11-15
Primary Completion	2027-12 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2026-02-13