Actively Recruiting
Personalized Metabolic Responses to Rapid, Slow and Resistant Starch
Led by Chalmers University of Technology · Updated on 2025-05-16
96
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
Sponsors
C
Chalmers University of Technology
Lead Sponsor
F
Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized Metabolic Responses to Rapid, Slow and Resistant Starch
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and post-menopausal women
- Age 30 to 75 years
- Body Mass Index (BMI) 27 to 40 kg/m2
- Waist circumference greater than 102 cm for men or greater than 88 cm for women
- Weight stable during previous 3 months (± 3 kg)
- Willingness to consume the intervention diets
- Ability to handle the monitoring devices
- Medications stable for the previous 14 days
- Signed informed consent
You will not qualify if you...
- Cardiovascular events (myocardial infarction or stroke) within the previous 6 months
- Diagnosis of diabetes or use of drugs affecting glucose metabolism (e.g., metformin, incretin analogues, SGLT-2 inhibitors)
- History of stomach or gastrointestinal conditions such as inflammatory bowel disease or Crohn's disease
- Colostomy, bowel resection, bariatric surgery, or other major gastrointestinal surgery
- Renal or liver failure (creatinine less than 1.7 mg/dl and liver enzymes less than twice normal)
- Anemia below age- and sex-specific normal ranges at screening
- Blood donation or participation in a study with blood sampling within 30 days prior to inclusion
- Antibiotic treatment within the past 3 months or planned during the study
- Habitual use of probiotic or prebiotic supplements or foods enriched with probiotics
- Celiac disease
- Vegan or vegetarian diet incompatible with study diets
- Intense physical activity regimen (more than 7 hours/week moderate or more than 3 hours/week high intensity)
- History of drug or alcohol abuse
- Inability to understand written and spoken Swedish
- Any other reason judged by investigators for unsuitability to participate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clinical Trial Center, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 413 46
Actively Recruiting
Research Team
A
Anna Hjort
CONTACT
R
Rikard Landberg
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
3
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