Clinical trial NCT06677333: The Effect of Increasing Dietary Protein on the Gut Microbiome and Its Metabolites
Official title: The Effect of Increasing Dietary Protein on the Gut Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Adults
Keywords: gut microbiota
dietary protein
gut metabolites
gut metabolome
dietary purines
gut microbiome
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 87
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to consume 50 g of whey or pea protein for seven days.
Primary purpose: BASIC_SCIENCE

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.

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 (\&lt;600 METS per week)

Primary outcomes:
measure: Fecal allantoin
timeFrame: A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.
Secondary outcomes:
measure: Changes in fecal bacterial species before and after increasing dietary protein intake (pea or whey) by 50 grams for seven days
timeFrame: A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.
measure: Changes in fecal metabolites before and after increasing dietary protein intake (pea or whey) by 50 grams for seven days
timeFrame: A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center New Orleans
state: Louisiana
Study officials:
affiliation: APUS/LSUHSC
name: Lauri O. Byerley, PhD
role: PRINCIPAL_INVESTIGATOR
References: