Recruiting

Microbiota Analysis

Sponsor:

Tufts University

Code:

NCT07220369

Conditions

Gut Microbiota

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

plant-based meat alternative entrees

mini-pill

meat based entree

Study Details

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

Study ID

NCT07220369

Start date

Sep 8, 2025

Status verified date

Oct, 2025

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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 entrĂ©es
  • 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Device Feasibility

Interventions and Outcome Measures

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

Interventions

plant-based meat alternative entrees

2 plant-based meat alternatives per day

mini-pill

mini-pills which sample at different locations in the gut

meat based entree

2 meat based entrees per day

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 and Locations

Central contacts

Alice H Lichtenstein, D.Sc.

617 556-3127alice.lichtenstein@tufts.edu

Jean Galluccio, BS

617 556-3121jean.galluccio@tufts.edu

Locations

Jean Mayer Human Nutrition Research Center on Aging

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Volunteer Services

800-738-7555

More Information

Sponsor

Tufts University

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • gut
  • mini-pill
  • gut sampling
  • gut microbiota

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tufts University on 2025-10-30.