Gut Mini-Pill Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts University
Study ID
NCT07220369
Status
Recruiting
Apply to this trial

Conditions

  • Gut Microbiota

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • plant-based meat alternative entrees — OTHER
    2 plant-based meat alternatives per day
  • mini-pill — DEVICE
    mini-pills which sample at different locations in the gut
  • meat based entree — OTHER
    2 meat based entrees per day

Study Details

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.

Key Dates

Start date
Sep 8, 2025
Status verified
Oct 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Plant-based meat alternative entree
    Entree that is composed of a plant-based meat alternative
  • Experimental: meat entree
    entree that is composed of meat

Primary Outcome Measure

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 [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Jean Mayer Human Nutrition Research Center on AgingBostonMassachusetts02111
Volunteer Services
800-738-7555

Find similar trials in Boston, MA

By research site
Jean Mayer Human Nutrition Research Center on Aging· Boston, MA

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