Impact of Protein Source on Gut Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2023-04-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Diet, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study is designed as a single-blinded randomized crossover trial in which individuals will be assigned to 2 groups. One group 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. The second group will receive the isolates in the opposite order.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Subjects will be blinded as to which protein type they are receiving.

Study Groups

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Pea protein to egg white protein

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.

Group Type EXPERIMENTAL

Protein isolate

Intervention Type DIETARY_SUPPLEMENT

The indicated protein isolates will be given to subjects as their major protein source

Egg white protein to pea protein

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.

Group Type EXPERIMENTAL

Protein isolate

Intervention Type DIETARY_SUPPLEMENT

The indicated protein isolates will be given to subjects as their major protein source

Interventions

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Protein isolate

The indicated protein isolates will be given to subjects as their major protein source

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes