Gut Mini-Pill Study for Diet and Microbiota

This study is testing a new way to understand how your diet affects your gut bacteria (microbiota). Researchers are using a small, swallowable device called a "mini-pill" to collect samples from different parts of your digestive system. You would eat either plant-based meat alternative entrees or meat-based entrees. The main goal is to see if these mini-pills can successfully show changes in your gut bacteria after eating these different diets over 8 weeks. To join, you should be between 50 and 75 years old, a man or postmenopausal woman, and have normal digestive, kidney, and liver function. You also need to be willing to swallow the mini-pills and collect stool samples. The study's status is currently unclear.

Study design
This is a randomized-controlled double-blind crossover trial with a planned enrollment of 30 participants. It involves two phases where participants will switch between diets.
What's involved
You would consume provided meals (either meat or plant-based meat alternatives) for up to 3 weeks in each phase. After 2 weeks on each diet, you would swallow 6 mini-pills and collect stool samples until all mini-pills are recovered, which can take 2 to 6 days.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at 8 weeks, indicating follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07220369

Gut Mini-Pill Study

Recruiting
NAAges 50–75InterventionalDevice feasibility
Tufts University
~30 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:plant-based meat alternative entreesmini-pillmeat based entree

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Test feasibility of the mini-pill to characterize differential changes inducted by a meat-rich and plant-based meat alternative-rich diet on the gut microbial profile
Measured over 8 weeks
Gut Microbiota

NCT07220369

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Jean Mayer Human Nutrition Research Center on Aging

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Alice H Lichtenstein, D.Sc. · PRINCIPAL_INVESTIGATOR · Tufts University

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Eligibility criteria

Inclusion

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

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.
  • Test feasibility of the mini-pill to characterize differential changes inducted by a meat-rich and plant-based meat alternative-rich diet on the gut microbial profile8 weeks

    Using luminal content collected by the gut mini-pill to compare the microbiome and metabolome after subjects consumed a meat-rich and plant-based meat alternative-rich diet