Gut Mini-Pill Study
ConditionGut Microbiota
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorTufts University
About this trial
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.
Eligibility criteria
Qualifiers
Men and postmenopausal women
Age >50 to <75 years
BMI >20 to <35 kg/m2
Normotensive with or without medication
Disqualifiers
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
Trial design
Treatments tested in this trial
- plant-based meat alternative entrees
- mini-pill
- meat based entree
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov