Personalized Metabolic Responses to Rapid, Slow and Resistant Starch

NCT06897241 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-05-16

No results posted yet for this study

Summary

The study aims to investigate how individuals with varying gut microbiota composition and AMY1 gene copy number respond to three different types of starch. A 12-week trial will therefore be conducted, where all participants will go through three different 17-day interventions in a randomized order. Each intervention will contain a different type of starch:

A) Resistant starch B) Slow digestible starch C) Rapid digestible starch

Each intervention will contain a preparation day, a meal challenge test day at clinic, a 14-day dietary intervention at home followed by a follow up visit at clinic. The interventions will be separated with a 14-day wash-out period, where participants are consuming their normal food.

Blood, saliva and fecal samples will be collected during the trial, together with data from continuous glucose monitoring and body measurements. Questionnaires on dietary intake and lifestyle, food preferences, self-reported appetite, health-related quality of life, sleep quality and daytime sleepiness will also be filled out by the participants.

Conditions

  • Adults With Overweight and Obesity

Interventions

OTHER

Resistant starch

Participants will consume 80 grams of carbohydrates from resistant starch during the meal challenges and two times daily during the 14-day intervention period

OTHER

Slow digestible starch

Participants will consume 80 grams of carbohydrates from slow digestible starch during the meal challenges and two times daily during the 14-day intervention period

OTHER

Rapid digestible starch

Participants will consume 80 grams of carbohydrates from rapid digestible starch during the meal challenges and two times daily during the 14-day intervention period

Sponsors & Collaborators

  • Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy

    collaborator UNKNOWN
  • Göteborg University

    collaborator OTHER
  • Chalmers University of Technology

    lead OTHER

Principal Investigators

  • Rikard Landberg · Chalmers University of Technology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-04-08
Primary Completion
2026-05-01
Completion
2026-05-01

Countries

  • Sweden

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 NCT06897241 on ClinicalTrials.gov