Tufts University
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.
The ingestible mini-pill is a non-invasive, single-use, passive collection device that is not intended for diagnosis or treatment. The mini-pills have already been developed, tested and validated by two Tufts researchers, Drs. Sameer Sonkusale (School of Engineering) and Giovanni Widmer (School of Veterinary Medicine), in vitro, ex vitro, and in vivo in animal models (Supplement 1: Research Strategy and Supplement 2: Soft Autonomous Ingestible Device for Sampling the Small Intestinal Microbiome, Del-Rio-Ruiz R et al., manuscript in review). A NSR device designation is being sought from the IRB…
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…
2 plant-based meat alternatives per day
mini-pills which sample at different locations in the gut
2 meat based entrees per day
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