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Impact of Protein Source on Gut Health

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Stony Brook University

Status

Completed

Conditions

Diet, Healthy

Treatments

Dietary Supplement: Protein isolate

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT05619939
2022-00427

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • BMI of 18-29.9

Exclusion 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 eggs
  • Those having taken probiotics or antibiotics within 1 month of starting the study
  • Those who are pregnant or plan to become pregnant

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 2 patient groups

Pea protein to egg white protein
Experimental group
Description:
This arm will receive 10 days of pea protein isolate followed by 10 days of consuming egg white protein isolate, with the two treatment periods separated by a 14-day washout period.
Treatment:
Dietary Supplement: Protein isolate
Egg white protein to pea protein
Experimental group
Description:
This arm will receive 10 days of egg white protein isolate followed by 10 days of consuming pea protein isolate, with the two treatment periods separated by a 14-day washout period.
Treatment:
Dietary Supplement: Protein isolate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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