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NCT05619939
Impact of Protein Source on Gut Health
Conditions: Diet, Healthy
Sex: All
Ages: 18 Years – 30 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 32
Sponsor: Stony Brook University
Location: United States
Summary
The gastrointestinal (GI) tract is a central hub for human health given its essential role in nutrient absorption, waste production and immunity.
Diet is a major contributor to gut health including affecting the incidence and severity of GI disease.
This is mediated, at least in part, by the presence of microbiota, a highly diet-dependent biome.
In fact, dietary changes are capable of altering bacterial populations and/or microbial metabolism, which in turn, controls the type and abundance of small molecules being produced in the gut, many of which can exert biological effects.
Several lines of evidence suggest that dietary protein in particular, can impact gut health.
Therefore, this trial will test whether dietary protein type differentially impacts gut function in humans by carrying out a single-blinded randomized cross-over controlled feeding study in healthy individuals.
Subjects will be provided with an individualized very low protein diet augmented with pea- or egg white-derived protein supplements, as their major protein source.
The impact of consuming pea vs. egg white protein on 1) the fecal metabolome, 2) gut barrier function and 3) gastrointestinal symptoms will be determined.
Eligibility Criteria
Inclusion Criteria:BMI of 18-29.9Exclusion Criteria:Those with a history of significant illness including diabetes, renal, liver or cardiovascular disease, malnutrition, GI disease (including IBS, IBD, chronic constipation or diarrhea), mental illness (i.e.
depression, bipolar disorder)Those adhering to a vegan diet or vegetarian diet exclusive of eggsThose having taken probiotics or antibiotics within 1 month of starting the studyThose who are pregnant or plan to become pregnant
Source: ClinicalTrials.gov (NCT05619939). StuddyBuddy aggregates publicly available trial information.