Gut Mini-Pill Study

NCT07220369 | Recruiting DMC

• 1 other identifier: 5011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gut Microbiota

Keywords

gut; mini-pill; gut sampling; gut microbiota

Outcome Measures

Primary Outcomes (1)

• 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

  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

  8 weeks

Secondary Outcomes (1)

• Test feasibility of the mini-pill to characterize differential changes inducted by a meat-rich and plant-based meat alternative-rich diet on cardiometabolic risk factors

  8 weeks

Study Arms (2)

Plant-based meat alternative entree

EXPERIMENTAL

Entree that is composed of a plant-based meat alternative

Other: plant-based meat alternative entrees; Device: mini-pill

meat entree

EXPERIMENTAL

entree that is composed of meat

Device: mini-pill; Other: meat based entree

Interventions

plant-based meat alternative entrees OTHER

2 plant-based meat alternatives per day

Plant-based meat alternative entree

mini-pill DEVICE

mini-pills which sample at different locations in the gut

Plant-based meat alternative entree; meat entree

meat based entree OTHER

2 meat based entrees per day

meat entree

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Jean Mayer Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

RECRUITING

Study Officials

• Alice H Lichtenstein, D.Sc.

  Tufts University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice H Lichtenstein, D.Sc.

CONTACT

617 556-3127; alice.lichtenstein@tufts.edu

Jean Galluccio, BS

CONTACT

617 556-3121; jean.galluccio@tufts.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Research Team

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 23, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (1)