Personalized Metabolic Responses to Rapid, Slow and Resistant Starch

Recruiting now · Not applicable

Conditions studied: Adults With Overweight and Obesity

In brief

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.

Key facts

Study ID

NCT06897241

Run by

Chalmers University of Technology

People needed

96

Starts

2025-04-08

Expected to finish

2026-05-01

Last updated by the study team

2025-05-16

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Cardiovascular events (myocardial infarction or stroke) during the previous 6 months
• Diagnosis of diabetes (any type) or use of any drug who can interfere with glucose homeostasis (i.e., metformin, incretin analogues, SGLT-2 inhibitors)
• History of stomach or gastrointestinal conditions (inflammatory bowel disease, Crohn's disease, malabsorption, etc.)
• Colostomy, bowel resection, bariatric surgery or other major gastrointestinal surgery
• Renal or liver failure (creatinine <1.7 mg/dl and alanine aminotransferase/aspartate aminotransferase < 2 times than normal values, respectively)
• Anemia (hemoglobin below the age and sex specific normal reference ranges at screening)
• Blood donation (or participation in a clinical study with blood sampling) within 30 days prior to inclusion
• Having been treated with antibiotics within the past 3 months or planning to undergo treatment during the study period.
• Habitual use of probiotic/prebiotic supplements or foods enriched in probiotics
• Celiac disease
• Vegan/vegetarian diet (or a diet incompatible with protocol diets)
• Intense physical activity regimen (> 7 h/week of moderate intensity or > 3 h/week of high intensity)
• History of drug or alcohol abuse
• Not able to understand written and spoken Swedish
• Any other reason for lack of suitability for participation in the trial, as judged by the principal investor or co-principal investigator

Where it is running

• Clinical Trial Center, Sahlgrenska University Hospital — Gothenburg, Västra Götaland County, Sweden (enrolling)

Full record on ClinicalTrials.gov

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