Clinical Trial

Personalized Metabolic Responses to Rapid, Slow and Resistant Starch

Study acronym: PerStarch
Recruiting
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Record status
This record was last updated May 16, 2025 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-20.
Status change: Not Yet Recruiting → Recruiting 2025-05-14
Trial Details
NCT Number NCT06897241
Lead Sponsor Chalmers University of Technology
Collaborators: Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy, Göteborg University
Conditions Adults With Overweight and Obesity
Enrollment 96 participants
Start Date 2025-04-08
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-16