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New treatment option for Adults With Overweight and Obesity
Official title Personalized Metabolic Responses to Rapid, Slow and Resistant Starch
ClinicalTrials.gov ID: NCT06897241
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 75
You may be able to join if
- 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)
You likely can't join if
- 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...
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Västra Götaland County, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Västra Götaland County, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.