Testing how adults with overweight or obesity respond to different types of starch
Studies how adults with overweight or obesity respond to starch types in food.
Plain-language title generated from the registry record
Registry title: Personalized Metabolic Responses to Rapid, Slow and Resistant Starch
Key facts
- Where
- Gothenburg, SwedenSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 75 years old?
Source: NCT06897241, who can take part
Where in Sweden
- Clinical Trial Center, Sahlgrenska University HospitalGothenburg, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chalmers University of Technology
- Trial code
- NCT06897241
- Record updated
- 16 May 2025
- Original description
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:Read full original descriptionShow less
Personalized Metabolic Responses to Rapid, Slow and Resistant Starch (PerStarch)
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.
Inclusion: 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: 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; History of stomach or gastrointestinal conditions (inflammatory bowel disease, Crohn's disease, malabsorption, etc.); Celiac disease; History of drug or alcohol abuse; 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); 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.