NCT07220369 · Tufts University
Gut Mini-Pill Study
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 entrées
- 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.
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 30, 2025 · Source of record for eligibility and locations