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

The Effect of Increasing Dietary Protein on the Gut Microbiota

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06677333
Acronym
PSGM
Enrollment
87
Registered
2024-11-06
Start date
2023-02-01
Completion date
2023-11-30
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Adults

Keywords

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

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.

Interventions

OTHERWhey Protein

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

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

Sponsors

Louisiana State University Health Sciences Center in New Orleans
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Fecal allantoinA 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

MeasureTime frameDescription
Changes in fecal bacterial species before and after increasing dietary protein intake (pea or whey) by 50 grams for seven daysA fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.The relative abundance of fecal bacterial species before and after consuming an additional 50 grams of pea or whey protein above the participant's usual dietary protein intake for seven days will be compared for each group to identify which species have significantly increased or decreased.
Changes in fecal metabolites before and after increasing dietary protein intake (pea or whey) by 50 grams for seven daysA fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.The intensity of fecal metabolites will be measured using mass spectrometry. The difference before and after consuming an additional 50 grams of pea or whey protein above the participant's usual dietary protein intake for seven days will be compared for each group to identify those metabolites that have significantly increased or decreased.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026