Investigating how different starch types affect glucose metabolism in overweight adults
Personalized Metabolic Responses to Rapid, Slow and Resistant Starch (PerStarch)
This study is testing how different types of starch affect blood sugar levels in overweight adults with different gut bacteria and gene variations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Chalmers University of Technology Academic / other |
| Locations | 1 site (Gothenburg, Västra Götaland County) |
| Trial ID | NCT06897241 on ClinicalTrials.gov |
What this trial studies
This study examines the metabolic responses of individuals with varying gut microbiota and AMY1 gene copy number to three types of starch: resistant, slow digestible, and rapid digestible. Over a 12-week period, participants will undergo a randomized, cross-over feeding intervention, where they will consume each type of starch for 14 days, separated by wash-out periods. Blood, saliva, and fecal samples will be collected to analyze glucose metabolism and gut microbiota composition. Participants will also complete questionnaires regarding their dietary intake, lifestyle, and health-related quality of life.
Who should consider this trial
Good fit: Ideal candidates are men and post-menopausal women aged 30-75 with a BMI between 27-40 kg/m2.
Not a fit: Patients with diabetes, recent cardiovascular events, or significant gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized dietary recommendations for improving glucose metabolism in overweight and obese individuals.
How similar studies have performed: While there is ongoing research into personalized nutrition based on gut microbiota, this specific approach to starch types and glucose metabolism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 (\> 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 this trial is running
Gothenburg, Västra Götaland County
- Clinical Trial Center, Sahlgrenska University Hospital — Gothenburg, Västra Götaland County, Sweden (Recruiting)
Study contacts
- Principal investigator: Rikard Landberg — Chalmers University of Technology
- Study coordinator: Anna Hjort
- Email: anna.hjort@chalmers.se
- Phone: 0046317722848
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.