Louisiana State University Health Sciences Center New Orleans
New Orleans, Louisiana, 70112, United States
NCT Number: NCT06677333
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.
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Notify Me25 year and older
All sexes
Interventional
Not applicable
New Orleans, Louisiana, 70112, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: A 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.
Time frame: A 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.
Louisiana State University Health Sciences Center in New Orleans
Other
The Effect of Increasing Dietary Protein on the Gut Microbiota
Acronym: PSGM
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