The Effect of Increasing Dietary Protein on the Gut Microbiome and Its Metabolites

NCT06677333 | Completed

• 1 other identifier: 5008
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the effect of dietary protein not absorbed in the small intestine on the bacteria in the large intestine and the metabolites those bacteria produce when they break down the protein. The three specific goals are:

1. 1.Determine if increasing dietary protein increases the purine breakdown product, allantoin, as observed in our previous study.
2. 2.Establish a model to examine the effect of dietary protein on the gut microbiota and metabolites.
3. 3.Identify gut bacteria and metabolite changes that occur with increased consumption of animal (whey) or plant (pea) protein sources.

Conditions

Health Adults

Keywords

gut microbiota; dietary protein; gut metabolites; gut metabolome; dietary purines; gut microbiome

Outcome Measures

Primary Outcomes (1)

• Fecal allantoin

  A cross-sectional study the investigators conducted found that healthy individuals who reported consuming, on average, 150 gms of protein daily had a higher fecal allantoin. This study is a pre/post-randomized controlled trial to confirm that observation. It will determine if consuming 50 gms more protein daily increases fecal allantoin.

  A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.

Secondary Outcomes (2)

• Changes in fecal bacterial species before and after increasing dietary protein intake (pea or whey) by 50 grams for seven days

  A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.

• Changes in fecal metabolites before and after increasing dietary protein intake (pea or whey) by 50 grams for seven days

  A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.

Study Arms (2)

Whey protein supplement

EXPERIMENTAL

This group of participants will consume 50 g of whey protein supplement daily.

Other: Whey Protein

Pea protein supplement

EXPERIMENTAL

This group of participants will consume 50 g of pea protein supplement daily.

Other: Pea protein

Interventions

Whey Protein OTHER

This intervention will add 50 g of a whey or pea protein supplement to their usual dietary intake.

Whey protein supplement

Pea protein OTHER

This intervention will add 50 g of a pea protein supplement to their usual dietary intake.

Pea protein supplement

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• male or female
• located in the contiguous United States

You may not qualify if:

• Taken any prebiotics in the last week
• Taken any probiotics in the last week
• Taken any prescription medications other than oral contraceptives
• Taken antibiotics sometime in the last three months
• Taken any diarrhea inhibitors in the last week
• Taken any laxatives in the last week
• Taken any dietary supplement(s)
• Diagnosed with cancer
• Diagnosed with an inflammatory disease of the GI tract, such as irritable bowel disease
• Experienced long-haul COVID fatigue
• Were physically inactive (\<600 METS per week)

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (1)

Louisiana State University Health Sciences Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Interventions

Whey Proteins; Pea Proteins

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Proteins, Dietary; Plant Proteins

Study Officials

• Lauri O. Byerley, PhD

  APUS/LSUHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to consume 50 g of whey or pea protein for seven days.

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: February 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 6, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted six months after article publication and will be accessible for up to 24 months.
• Access Criteria: Qualified researchers engaged in independent scientific research can request access to this study's IPD, which will be provided following the review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). D

Locations

US (1)