Impact of Protein Source on Gut Health

NCT05619939 | Completed

• 1 other identifier: 2022-00427
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet, Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Adherence to study diets

  Daily over two, 10-day periods

• Amount of study diets consumed

  Daily over two, 10-day periods

Study Arms (2)

Pea protein to egg white protein

EXPERIMENTAL

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

Egg white protein to pea protein

EXPERIMENTAL

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

Interventions

Protein isolate DIETARY_SUPPLEMENT

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

Egg white protein to pea protein; Pea protein to egg white protein

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI of 18-29.9

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead
• USDA Beltsville Human Nutrition Research Center: collaborator

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Study Officials

• David C Montrose, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded as to which protein type they are receiving.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: January 18, 2023
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

US (1)