Status:
RECRUITING
Personalized Metabolic Responses to Rapid, Slow and Resistant Starch
Lead Sponsor:
Chalmers University of Technology
Collaborating Sponsors:
Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy
Göteborg University
Conditions:
Adults With Overweight and Obesity
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief 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,...
Detailed Description
Up to 400 men and women with overweight or obesity will be invited for screening. Participants will provide stool-, saliva-, and fasting blood samples, alongside undergoing anthropometric measurements...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06897241
Start Date
April 8 2025
End Date
May 1 2026
Last Update
May 16 2025
Active Locations (1)
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1
Clinical Trial Center, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 413 46