Impact of Protein Source on Gut Health

Not Applicable

Completed

• Conditions: Diet, Healthy
• Interventions: Dietary Supplement: Protein isolate

• Registration Number: NCT05619939
• Lead Sponsor: Stony Brook University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-11-09
• Study First Posted: 2022-11-17
• Study Start: 2023-01-18
• Primary Completion: 2023-04-28
• Study Completion: 2023-04-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• BMI of 18-29.9

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pea protein to egg white protein	Protein isolate	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.
Egg white protein to pea protein	Protein isolate	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.

Primary Outcome Measures

Name	Time	Method
Fecal metabolome	This analysis will be carried out at baseline and the end of each treatment period, entailing 4 measurements over an approximately 36 day period	Mass-spectrometry based analysis of the relative abundance of metabolites will be carried out on feces.
Intestinal permeability	This analysis will be carried out at baseline and the end of each treatment period, entailing 4 measurements over an approximately 36 day period	Subjects will undergo lactulose-mannitol test to inform on gut permeability

Secondary Outcome Measures

Name	Time	Method
Adherence to study diets	Daily over two, 10-day periods	consumption of study diets will be recorded through subject-reported surveys before and after eating.
Amount of study diets consumed	Daily over two, 10-day periods	Subjects will take pictures of food items before and after eating to assess the amount of each study diet item consumed.

Trial Locations

Locations (1)

Stony Brook University; 🇺🇸 Stony Brook, New York, United States