Personalized Metabolic Responses to Rapid, Slow and Resistant Starch (PerStarch)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• Men and post-menopausal women

• Age 30-75 years

• BMI 27-40 kg/m2

• Waist circumference \> 102/88 cm for men/women

• Weight stable during previous 3 months (± 3 kg)

• Willingness to consume the intervention diets

• Ability to deal with the monitoring devices

• Medications stable for the previous 14 days

• Signed informed consent

Locations
Other Locations
Sweden
Clinical Trial Center, Sahlgrenska University Hospital
RECRUITING
Gothenburg
Contact Information
Primary
Anna Hjort
anna.hjort@chalmers.se
0046317722848
Backup
Rikard Landberg
rikard.landberg@chalmers.se
0046317722732
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 96
Treatments
Experimental: 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
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Chalmers University of Technology
Collaborators: Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy, Göteborg University

This content was sourced from clinicaltrials.gov