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Gut Mini-Pill Study

NCT07220369 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-30

No results posted yet for this study

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

Interventions

OTHER

plant-based meat alternative entrees

2 plant-based meat alternatives per day

DEVICE

mini-pill

mini-pills which sample at different locations in the gut

OTHER

meat based entree

2 meat based entrees per day

Sponsors & Collaborators

  • Tufts University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2027-08-31
Completion
2028-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07220369 on ClinicalTrials.gov