Personalized Metabolic Responses to Rapid, Slow and Resistant Starch (NCT06897241) | Clinical Trial Compass
RecruitingNot Applicable
Personalized Metabolic Responses to Rapid, Slow and Resistant Starch
Sweden96 participantsStarted 2025-04-08
Plain-language 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.
Who can participate
Age range
30 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Propionate
Timeframe: During meal challenge day (at the beginning of each intervention)