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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein supplement | Experimental | This group of participants will consume 50 g of whey protein supplement daily. |
|
| Pea protein supplement | Experimental | This group of participants will consume 50 g of pea protein supplement daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey Protein | Other | This intervention will add 50 g of a whey or pea protein supplement to their usual dietary intake. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal allantoin | 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. | A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fecal bacterial species before and after increasing dietary protein intake (pea or whey) by 50 grams 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauri O. Byerley, PhD | APUS/LSUHSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana State University Health Sciences Center New Orleans | New Orleans | Louisiana | 70112 | United States |
Data requests can be submitted six months after article publication. Qualified researchers engaged in independent scientific research can request access to this study's IPD, which will be provided following the review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). Data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. For more information or to submit a request, please contact lbyerl@lsuhsc.edu.
Data requests can be submitted six months after article publication and will be accessible for up to 24 months.
Qualified researchers engaged in independent scientific research can request access to this study's IPD, which will be provided following the review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). D
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| D000078724 | Pea Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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Participants will be randomized to consume 50 g of whey or pea protein for seven days.
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| Pea protein | Other | This intervention will add 50 g of a pea protein supplement to their usual dietary intake. |
|
| 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 | 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. | A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days. |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D014674 | Plant Proteins, Dietary |
| D010940 | Plant Proteins |