Gut Mini-Pill Study
Evaluation of Ingestible Mini-pill for Gastrointestinal Regional Luminal Content Sampling
Tufts University
30 participants
Sep 8, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this proof-of-concept study in humans is to determine if a noninvasive, ingestible device, called a "mini-pill", can collect gastrointestinal (GI) luminal content samples from 2 different locations along the GI tract after consumption of diets differing in protein source (meat and plant-based meat alternatives). The mini-pills will be recovered in the stool. We will analyze the microbial profile of the mini-pill contents and in stool, and also measure blood biomarkers related to cardiometabolic risk, to better understand the relationship between diet, microbiota and health.
Eligibility
Inclusion Criteria10
- Men and postmenopausal women
- Age >50 to <75 years
- BMI >20 to <35 kg/m2
- Normotensive with or without medication
- Normal gastrointestinal function with regular bowel movements at least once every other day
- Normal kidney and liver function
- Willingness to swallow the mini-pills
- Willingness to collect and return multiple stool samples
- Adequate refrigerator and freezer space to store study entrées
- Intent to remain in the greater Boston area during the intervention periods
Exclusion Criteria21
- Individuals self-reporting adhering to any type of vegetarian diet
- Lack of willingness to restrict fish intake to less than once per week during the dietary intervention phases
- Allergy/intolerance/religious reasons to avoid study foods or food ingredients, including known hypersensitivity to Blue 1 food coloring and wheat gluten.
- Regular use of prebiotics or probiotics within the past 3 months
- Regular use of laxatives or fiber supplements
- Chronic constipation
- Chronic use of antibiotics (except topical)
- Regular use of stomach acid lowering and weight loss medications such as GLP-1 agonists
- Use of dental prophylaxis
- Planned colonoscopy 2 months prior to or during the study period
- Gastroparesis
- Swallowing disorder, or inability or difficulty taking pills
- Malabsorptive and inflammatory bowel disease, diverticulosis, and history of diverticulitis, gastric/ esophageal/intestinal surgery, including lap banding or bariatric surgery.
- History of bowel obstruction, pancreas and liver disorders.
- Any form of active substance abuse or dependence (including drug or alcohol abuse). This information will be stored in REDCAP in a subsection that has no identifiers.
- Established major chronic diseases such as cardiovascular disease, diabetes, active cancer within the last 5 years, or any significant medical condition at the study MD's discretion
- A clinical condition that, in the judgment of the study MD or principal investigator, could potentially pose a health risk to the subject while involved in the study.
- Unwillingness to adhere to study protocol
- Intent to increase or decrease body weight during the study period
- No Social Security number (for payment and IRS forms).
- Individuals who directly report to any member of the research team.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
2 plant-based meat alternatives per day
mini-pills which sample at different locations in the gut
2 meat based entrees per day
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07220369