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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

plant-based meat alternative entrees
Other intervention
2 plant-based meat alternatives per day
mini-pill
Device
mini-pills which sample at different locations in the gut
meat based entree
Other intervention
2 meat based entrees per day

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Plant-based meat alternative entreeExperimental treatment 2 interventions

Group B: meat entreeExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

Using luminal content collected by the gut mini-pill to compare the microbiome and metabolome after subjects consumed a meat-rich and plant-based meat alternative-rich diet

Time frame

8 weeks

Secondary outcomes

Test feasibility of the mini-pill to characterize differential changes inducted by a meat-rich and plant-based meat alternative-rich diet on cardiometabolic risk factors

Using luminal content collected by the gut mini-pill to compare the cardiometabolic after subjects consumed a meat-rich and plant-based meat alternative-rich diet

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tufts University

Lead sponsor

Source ClinicalTrials.gov

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