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Clinical Trials/NCT06677333
NCT06677333
Completed
Not Applicable

The Effect of Increasing Dietary Protein on the Gut Microbiota

Louisiana State University Health Sciences Center in New Orleans1 site in 1 country87 target enrollmentFebruary 1, 2023
ConditionsHealth Adults

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Adults
Sponsor
Louisiana State University Health Sciences Center in New Orleans
Enrollment
87
Locations
1
Primary Endpoint
Fecal allantoin
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
November 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Fecal allantoin

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

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.

Secondary Outcomes

  • 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 Sites (1)

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