Study #3190 Gut Mini-pill Study

Men and postmenopausal women, between 50 and 75 years old.

The purpose of this study is to compare whether consuming 2 meat entrees or 2 plant-based meat alternative entrees per day changes the types of microorganisms in your gut and stool, as well as blood biomarkers related to heart disease risk. We will use an ingestible device called a mini-pill to sample gut contents. The results of this study will help to better understand the relationship between diet, gut microbes and health.

Inclusion Criteria:

• Age >50 years to ≤75
• Men and postmenopausal women
• BMI >20 and <35 kg/m2
• No dietary pattern that excludes meat products
• Willing to consume 2 meat or plant-based meat alternative entrees per day
• Usual pattern of bowel movements at least every other day

Major Exclusions:

• Inability or difficulty in taking pills
• Gastrointestinal disorders and other major chronic diseases
• Taking medications or dietary supplements that will affect the study outcomes

Length of study:

• Approximately 8 weeks

Residency:

• None

Payment:

• Up to $575 for participants who qualify and complete the entire study.

Number of visits:

• 7 total visits to the center and 5 telephone-administered questionnaires
  • Weeks 1 and 6: 1 visit each, up to 2 hours
  • Weeks 2 and 7: 2 visits each, 1st visit approximately 10-15 mins and 2nd visit up to 2 hours
  • Weeks 3 and 8: at least 1 visit each phase, approximately 15 minutes each visit
  • Weeks 4 and 5: no visits
• These visits will involve collection of blood and stool samples, measurement of height, weight, waist circumference, and blood pressure, completing questionnaires either in person or over the telephone, picking up your study food items, and swallowing pills. You will also have to come into the center at least an additional 2 times to drop off stool samples.

Can I work?
Yes, but if subjects employed by Tufts University qualify to participate in the study, they cannot participate as subjects during hours in which they are being compensated by Tufts. Any members of the research team (or direct reports) are not eligible to participate.