NCT06897241Recruiting
Personalized Metabolic Responses to Rapid, Slow and Resistant Starch
Personalized Metabolic Responses to Rapid, Slow and Resistant Starch (PerStarch)
Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 20 Mar 2025
- Start date
- 8 Apr 2025
- Primary completion date
- 1 May 2026
- Lead sponsor
- Chalmers University of Technology
- Diseases
- Obesity
- NCT number
- NCT06897241
What you commit to
- Study type: Interventional
- Planned participants: 96
- From 8 Apr 2025 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cardiovascular events (myocardial infarction or stroke) during the previous 6 months
- Colostomy, bowel resection, bariatric surgery or other major gastrointestinal surgery
- 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.
Other illness
- History of stomach or gastrointestinal conditions (inflammatory bowel disease, Crohn's disease, malabsorption, etc.)
- Celiac disease
- History of drug or alcohol abuse
Lab values
- Diagnosis of diabetes (any type) or use of any drug who can interfere with glucose homeostasis (i.e., metformin, incretin analogues, SGLT-2 inhibitors)
- 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)
Other
- Habitual use of probiotic/prebiotic supplements or foods enriched in probiotics
- 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)
- 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
Who the study is looking for
- 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
Age in the registry: 30 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Trial Center, Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.