Investigating how different starch types affect glucose metabolism in overweight adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.