Personalized Metabolic Responses to Rapid, Slow and Resistant Starch
Personalized Metabolic Responses to Rapid, Slow and Resistant Starch (PerStarch)
Chalmers University of Technology
96 participants
Apr 8, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria15
- 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
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Interventions
Participants will consume 80 grams of carbohydrates from resistant starch during the meal challenges and two times daily during the 14-day intervention period
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
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06897241