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Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients

NCT03847701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-04-01

No results posted yet for this study

Summary

This is a monocentric, randomized, single-blind and controlled study with a parallel design (2 arms). The research hypothesis is that the diet high in Slow Digestible Starch (SDS) content (H-SDS) will lower the daylong glycemic response and improve the glycemic control just as metabolic, inflammatory, cardiovascular and oxidative stress parameters in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS). The hypothesis is that these differences in glycemic response and in metabolic, inflammatory, cardiovascular and oxidative stress parameters response can be observed after 3 months of diet.

Conditions

  • Type2 Diabetes

Interventions

OTHER

Balanced diet high in Slowly Digestible Starch

The carbohydrates present in high Slowly Digestible Starch diet were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during three months.

OTHER

Balanced diet low in Slowly Digestible Starch

The carbohydrates present in low-Slowly Digestible Starch diet were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during three months.

Sponsors & Collaborators

  • Centre de Recherche en Nutrition Humaine Rhone-Alpe

    collaborator OTHER

  • Biofortis Mérieux NutriSciences

    collaborator OTHER

  • Mondelēz International, Inc.

    lead INDUSTRY

Principal Investigators

  • Emmanuel DISSE, MD, PhD · Centre de Recherche en Nutrition Humaine Rhône-Alpes

  • Martine LAVILLE, MD, PhD · Centre de Recherche en Nutrition Humaine Rhône-Alpes

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2024-11-15
Completion
2024-11-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03847701 on ClinicalTrials.gov