Impact of Protein Source on Gut Health

Determining the Effect of Dietary Protein Source on Intestinal Health

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.

Study Overview

• Status: Completed
• Conditions: Diet, Healthy
• Intervention / Treatment: Dietary supplement: Protein isolate

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Protein isolate; The indicated protein isolates will be given to subjects as their major protein source
Experimental: 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.	Dietary supplement: Protein isolate; The indicated protein isolates will be given to subjects as their major protein source

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: USDA Beltsville Human Nutrition Research Center
• Investigators: Principal Investigator: David C Montrose, PhD, Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022-00427

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No