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Gut Mini-Pill Study

Tufts University · NCT07220369

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50–75 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
30
US sites recruiting
1
Study start
September 8, 2025
Record last updated
October 30, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: plant-based meat alternative entrees; mini-pill; meat based entree

Conditions: Gut Microbiota

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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.

Recruiting US locations

  • Jean Mayer Human Nutrition Research Center on Aging

    Boston, MA 02111

    Site contact: Volunteer Services · 800-738-7555

Study contacts (from the official record)

  • Alice H Lichtenstein, D.Sc. · 617 556-3127 · alice.lichtenstein@tufts.edu
  • Jean Galluccio, BS · 617 556-3121 · jean.galluccio@tufts.edu
Gut Mini-Pill Study (NCT07220369) | Bored Studies