Health AdultsPSGMNCT06677333
The Effect of Increasing Dietary Protein on the Gut Microbiome and Its Metabolites
A study testing Whey Protein and Pea protein in people with Health Adults, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Health Adults
- What is being tested?
- Whey Protein and Pea protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25 years old or older
- male or female
- located in the contiguous United States
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University Health Sciences Center New Orleans
New Orleans, Louisiana, 70112
About this study
Official title: The Effect of Increasing Dietary Protein on the Gut Microbiota
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:
- Determine if increasing dietary protein increases the purine breakdown product, allantoin, as observed in our previous study.
- Establish a model to examine the effect of dietary protein on the gut microbiota and metabolites.
- Identify gut bacteria and metabolite changes that occur with increased consumption of animal (whey) or plant (pea) protein sources.
Read the 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.
- Conditions
- Health Adults
- Being tested
- Whey Protein, Pea protein
- Keywords
- gut microbiota, dietary protein, gut metabolites, gut metabolome, dietary purines, gut microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey ProteinOther
This intervention will add 50 g of a whey or pea protein supplement to their usual dietary intake.
Pea proteinOther
This intervention will add 50 g of a pea protein supplement to their usual dietary intake.
| Study group | Role | What they receive |
|---|---|---|
| Whey protein supplement | Experimental | This group of participants will consume 50 g of whey protein supplement daily. Receives: Other: Whey Protein |
| Pea protein supplement | Experimental | This group of participants will consume 50 g of pea protein supplement daily. Receives: Other: Pea protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.
Secondary outcomes (2)
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.
Measured: 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.
Measured: A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Feb 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to consume 50 g of whey or pea protein for seven days.
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauri O. Byerley, PhD, Principal investigator, APUS/LSUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677333
- Sponsor's protocol ID
- 5008
- Acronym
- PSGM
- Status last verified
- Sep 2024
- First submitted
- 4 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Increasing Dietary Protein on the Gut Microbiota
- ClinicalTrials.gov ID
- NCT06677333
- Acronym / sponsor ID
- PSGM / 5008
- Conditions
- Health Adults
- Keywords
- gut microbiota, dietary protein, gut metabolites, gut metabolome, dietary purines, gut microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine if increasing dietary protein increases the purine breakdown product, allantoin, as observed in our previous study.
- Establish a model to examine the effect of dietary protein on the gut microbiota and metabolites.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to consume 50 g of whey or pea protein for seven days.
| Arm | Type | Receives |
|---|---|---|
| Whey protein supplement | Experimental | Other: Whey ProteinThis group of participants will consume 50 g of whey protein supplement daily. |
| Pea protein supplement | Experimental | Other: Pea proteinThis group of participants will consume 50 g of pea protein supplement daily. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 25 years old or older
- male or female
- located in the contiguous United States
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey ProteinThis intervention will add 50 g of a whey or pea protein supplement to their usual dietary intake. | Other | Whey protein supplement |
| Pea proteinThis intervention will add 50 g of a pea protein supplement to their usual dietary intake. | Other | Pea protein supplement |
Primary outcome
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.
2 secondary outcomes
Changes in fecal bacterial species before and after increasing dietary protein intake (pea or whey) by 50 grams for seven days
Time frame: 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
Time frame: A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: Yes. 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.
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauri O. Byerley, PhD principal investigator
APUS/LSUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein and Pea protein in people with Health Adults, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal allantoin (time frame: A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.