Actively Recruiting
Evaluation of Ingestible Mini-Pill for Sampling Gut Contents During Meat and Plant-Based Diets
Led by Tufts University · Updated on 2025-10-30
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether a noninvasive, ingestible device called a mini-pill can collect samples from two different locations in the gastrointestinal (GI) tract after people consume diets with different protein sources, such as meat and plant-based meat alternatives. This proof-of-concept study aims to analyze the microbial content collected by the mini-pills and stool samples, alongside blood biomarkers related to cardiometabolic risk, to better understand how diet, gut microbiota, and health are connected. Participants will follow two dietary phases in a randomized, double-blind crossover design, each lasting up to three weeks. During these periods, they will consume two daily entrees composed either of meat or plant-based meat alternatives. After two weeks on each diet, participants will swallow six mini-pills along with a blue food coloring dissolved in water. The mini-pills, designed to sample different gut locations, will be recovered from stool collected at home over several days. This protocol allows researchers to observe diet-induced changes in the gut microbiota over time. Participants will provide stool samples until all mini-pills are recovered, which may take two to six days. Researchers will analyze microbial profiles from the mini-pills and stool, as well as measure blood markers linked to cardiometabolic risk. The study requires participants to collect and return multiple stool samples, maintain certain dietary restrictions, and remain in the study area during the intervention. The overall study duration for each participant is approximately eight weeks, including diet phases and sample collection.
CONDITIONS
Brief Title
Gut Mini-Pill Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and postmenopausal women
- Age greater than 50 and less than 75 years
- Body mass index (BMI) greater than 20 and less than 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 mini-pills
- Willingness to collect and return multiple stool samples
- Adequate refrigerator and freezer space to store study entrees
- 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 the dietary intervention
- Allergy, intolerance, or religious reasons to avoid study foods or ingredients, including hypersensitivity to Blue 1 food coloring or 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 bariatric procedures
- History of bowel obstruction, pancreas or liver disorders
- Active substance abuse or dependence including drugs or alcohol
- Major chronic diseases such as cardiovascular disease, diabetes, or active cancer within the last 5 years
- Any significant medical condition that could pose health risk during the study
- Unwillingness to follow study protocol
- Intent to change body weight during the study
- No Social Security number (for payment and tax forms)
- Direct reporting to any member of the research team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks total (3 weeks per diet)
Participants follow two different diets, each for up to 3 weeks: one diet includes two plant-based meat alternative entrees per day, and the other includes two meat-based entrees per day. After 2 weeks on each diet, participants consume a provided breakfast meal and swallow 6 mini-pills with blue food coloring, then collect stool samples at home until all mini-pills are recovered.
1 visit per diet period to swallow mini-pills; stool sample collection at home over 2 to 6 days after each mini-pill ingestion
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.
J
Jean Galluccio, BS
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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