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OpenTrials
Completed

NCT Number: NCT05619939

Impact of Protein Source on Gut 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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University

Stony Brook, New York, 11794, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein Isolate

Dietary Supplement

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

Primary outcomes

  1. Fecal metabolome

    Time frame: 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.

  2. Intestinal permeability

    Time frame: 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 outcomes

  1. Adherence to study diets

    Time frame: Daily over two, 10-day periods

    consumption of study diets will be recorded through subject-reported surveys before and after eating.

  2. Amount of study diets consumed

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • USDA Beltsville Human Nutrition Research Center

Registry information

Official study title

Determining the Effect of Dietary Protein Source on Intestinal Health

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 17, 2022
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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