Actively Recruiting
Gut Mini-Pill Study
Led by Tufts University · Updated on 2025-10-30
30
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gut Mini-Pill Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and postmenopausal women
- Age over 50 to under 75 years
- Body mass index (BMI) over 20 to under 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
You will not qualify if you...
- Following any type of vegetarian diet
- Unwillingness to restrict fish intake to less than once per week during dietary phases
- Allergy, intolerance, or religious reasons to avoid study foods or ingredients, including 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 or 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 difficulty taking pills
- Malabsorptive or inflammatory bowel disease, diverticulosis, history of diverticulitis, or gastrointestinal surgery including lap banding or bariatric surgery
- History of bowel obstruction, pancreas or liver disorders
- Active substance abuse or dependence including drug or alcohol abuse
- Established major chronic diseases such as cardiovascular disease, diabetes, active cancer within last 5 years, or other significant medical conditions at investigator discretion
- Any clinical condition posing a health risk during study participation
- Unwillingness to follow study protocol
- Intent to change body weight during study
- No Social Security number for payment and IRS forms
- Employment reporting directly to any member of the research team
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jean Mayer Human Nutrition Research Center on Aging
Boston, Massachusetts, United States, 02111
Actively Recruiting
Research Team
A
Alice H Lichtenstein, D.Sc.
CONTACT
J
Jean Galluccio, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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