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

NCT ID: NCT06677333

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-11-30

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. Determine if increasing dietary protein increases the purine breakdown product, allantoin, as observed in our previous study.

2. Establish a model to examine the effect of dietary protein on the gut microbiota and metabolites.

3. Identify gut bacteria and metabolite changes that occur with increased consumption of animal (whey) or plant (pea) protein sources.

Detailed Description

Healthy male and female participants were recruited following specific inclusion/exclusion criteria. Participants were excluded if they 1) were less than 25 years of age, 2) consumed pre or probiotics in the last week, 3) had taken any antibiotics in the last three months, 4) were taking any prescribed medicines for a chronic disease such as diabetes, hypertension, cancer, anxiety, depression, or GI-related diseases. and 4) had taken any laxatives or antidiarrhea inhibitors in the last week. The study design was pre/post, with each person serving as their own control. Interested participants were randomly assigned to one of two study groups: 50 g whey protein supplement or 50 g pea protein supplement. They were asked to consume the supplement along with their usual dietary intake. Participants were located within the contiguous USA and were sent a fecal collection kit, the protein supplement, and a shaker bottle using overnight shipping. We used the fecal collection kit developed by the Biocollective. A fecal sample was collected before and after the participant consumed the protein supplement daily for seven days. At both time points, the participants were asked to recall the foods they ate during the previous 24 hours using ASA24-2020, provide information on their physical activity (International Physical Activity Questionnaire, IPAQ), and answer questions about the stool sample they collected. The stool sample will be analyzed for the microbes and metabolites present. These will be correlated with the dietary protein they consume.

Conditions

Health Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Whey protein supplement

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

Group Type: EXPERIMENTAL

Whey Protein

Intervention Type: OTHER

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

Pea protein supplement

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

Group Type: EXPERIMENTAL

Pea protein

Intervention Type: OTHER

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

Interventions

Whey Protein

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

Intervention Type: OTHER

Pea protein

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauri O. Byerley, PhD

Role: PRINCIPAL_INVESTIGATOR

APUS/LSUHSC

Locations

Louisiana State University Health Sciences Center New Orleans

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

5008

Identifier Type: -

Identifier Source: org_study_id