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

Sponsor
Mondelēz International, Inc.
Study ID
NCT07408479
Status
Recruiting
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Conditions

  • Insulin Resistance

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Balanced diet high in Slowly Digestible Starch and Resistant Starch — OTHER
    Diet where all the starchy foods were selected based on their SDS and RS content. This diet needs to be easy to apply by subjects. It will be consumed during 2 months
  • Balanced diet low in Slowly Digestible Starch and Resistant Starch — OTHER
    Diet where all the starchy foods were selected based on their SDS and RS content. This diet needs to be easy to apply by subjects. It will be consumed during 2 months

Study Details

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 Dates

First listed
Feb 13, 2026
Start date
Nov 15, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: High SDS-RS diet
    Balanced diet containing high levels of Slowly digestible Starch (SDS) and Resistant Starch (RS)
  • Placebo Comparator: Low SDS-RS diet
    Balanced diet containing low levels of Slowly digestible Starch (SDS) and Resistant Starch (RS)

Primary Outcome Measure

Change in MAGE measured on 3 occasions between diets High or Low in SDS and RS [ Time Frame: Evaluations done before, after 1 week and after 2 months on a diet ]

Central Contacts

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