Diet, HealthyNCT05619939
Impact of Protein Source on Gut Health
A study testing Protein isolate in people with Diet, Healthy, run by Stony Brook University at 1 site in United States.
Trial summary
The gastrointestinal (GI) tract is a central hub for human health given its essential role in nutrient absorption, waste production and immunity. Diet is a major contributor to gut health including affecting the incidence and severity of GI disease. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- Protein isolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to 28 Apr 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of 18-29.9
Who cannot join
- Those with a history of significant illness including diabetes, renal, liver or cardiovascular disease, malnutrition, GI disease (including IBS, IBD, chronic constipation or diarrhea), mental illness (i.e. depression, bipolar disorder)
- Those adhering to a vegan diet or vegetarian diet exclusive of eggs
- Those having taken probiotics or antibiotics within 1 month of starting the study
- Those who are pregnant or plan to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Effect of Dietary Protein Source on Intestinal Health
The gastrointestinal (GI) tract is a central hub for human health given its essential role in nutrient absorption, waste production and immunity. Diet is a major contributor to gut health including affecting the incidence and severity of GI disease. This is mediated, at least in part, by the presence of microbiota, a highly diet-dependent biome. In fact, dietary changes are capable of altering bacterial populations and/or microbial metabolism, which in turn, controls the type and abundance of small molecules being produced in the gut, many of which can exert biological effects. Several lines of evidence suggest that dietary protein in particular, can impact gut health. Therefore, this trial will test whether dietary protein type differentially impacts gut function in humans by carrying out a single-blinded randomized cross-over controlled feeding study in healthy individuals. Subjects will be provided with an individualized very low protein diet augmented with pea- or egg white-derived protein supplements, as their major protein source. The impact of consuming pea vs. egg white protein on 1) the fecal metabolome, 2) gut barrier function and 3) gastrointestinal symptoms will be determined.
- Conditions
- Diet, Healthy
- Being tested
- Protein isolate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein isolateDietary supplement
The indicated protein isolates will be given to subjects as their major protein source
| Study group | Role | What they receive |
|---|---|---|
| Pea protein to egg white protein | Experimental | This arm will receive 10 days of pea protein isolate followed by 10 days of consuming egg white protein isolate, with the two treatment periods separated by a 14-day washout period. Receives: Dietary Supplement: Protein isolate |
| Egg white protein to pea protein | Experimental | This arm will receive 10 days of egg white protein isolate followed by 10 days of consuming pea protein isolate, with the two treatment periods separated by a 14-day washout period. Receives: Dietary Supplement: Protein isolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal metabolome
Mass-spectrometry based analysis of the relative abundance of metabolites will be carried out on feces.
Measured: This analysis will be carried out at baseline and the end of each treatment period, entailing 4 measurements over an approximately 36 day period
Intestinal permeability
Subjects will undergo lactulose-mannitol test to inform on gut permeability
Measured: This analysis will be carried out at baseline and the end of each treatment period, entailing 4 measurements over an approximately 36 day period
Secondary outcomes (2)
Adherence to study diets
consumption of study diets will be recorded through subject-reported surveys before and after eating.
Measured: Daily over two, 10-day periods
Amount of study diets consumed
Subjects will take pictures of food items before and after eating to assess the amount of each study diet item consumed.
Measured: Daily over two, 10-day periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start18 Jan 2023
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is designed as a single-blinded randomized crossover trial in which individuals will be assigned to 2 groups. One group will receive 10 days of pea protein isolate followed by 10 days of consuming egg white protein isolate, with the two treatment periods separated by a 14-day washout period. The second group will receive the isolates in the opposite order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Responsible party
- Principal investigator, David Montrose, Stony Brook University
- Investigators
- David C Montrose, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619939
- Sponsor's protocol ID
- 2022-00427
- Status last verified
- Apr 2024
- First submitted
- 9 Nov 2022
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Dietary Protein Source on Intestinal Health
- ClinicalTrials.gov ID
- NCT05619939
- Acronym / sponsor ID
- 2022-00427
- Conditions
- Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 17 Nov 2022 (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.
The gastrointestinal (GI) tract is a central hub for human health given its essential role in nutrient absorption, waste production and immunity. Diet is a major contributor to gut health including affecting the incidence and severity of GI disease. This is mediated, at least in part, by the presence of microbiota, a highly diet-dependent biome. In fact, dietary changes are capable of altering bacterial populations and/or microbial metabolism, which in turn, controls the type and abundance of small molecules being produced in the gut, many of which can exert biological effects. Several lines of evidence suggest that dietary protein in particular, can impact gut health. Therefore, this trial will test whether dietary protein type differentially impacts gut function in humans by carrying out a single-blinded randomized cross-over controlled feeding study in healthy individuals. Subjects will be provided with an individualized very low protein diet augmented with pea- or egg white-derived protein supplements, as their major protein source. The impact of consuming pea vs. egg white protein on 1) the fecal metabolome, 2) gut barrier function and 3) gastrointestinal symptoms will be determined.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is designed as a single-blinded randomized crossover trial in which individuals will be assigned to 2 groups. One group will receive 10 days of pea protein isolate followed by 10 days of consuming egg white protein isolate, with the two treatment periods separated by a 14-day washout period. The second group will receive the isolates in the opposite order.
| Arm | Type | Receives |
|---|---|---|
| Pea protein to egg white protein | Experimental | Dietary Supplement: Protein isolateThis arm will receive 10 days of pea protein isolate followed by 10 days of consuming egg white protein isolate, with the two treatment periods separated by a 14-day washout period. |
| Egg white protein to pea protein | Experimental | Dietary Supplement: Protein isolateThis arm will receive 10 days of egg white protein isolate followed by 10 days of consuming pea protein isolate, with the two treatment periods separated by a 14-day washout period. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI of 18-29.9
Key exclusion criteria (4 listed)
- Those with a history of significant illness including diabetes, renal, liver or cardiovascular disease, malnutrition, GI disease (including IBS, IBD, chronic constipation or diarrhea), mental illness (i.e. depression, bipolar disorder)
- Those adhering to a vegan diet or vegetarian diet exclusive of eggs
- Those having taken probiotics or antibiotics within 1 month of starting the study
- Those who are pregnant or plan to become pregnant
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 |
|---|---|---|
| Protein isolateThe indicated protein isolates will be given to subjects as their major protein source | Dietary supplement | Egg white protein to pea protein, Pea protein to egg white protein |
Primary outcome
Fecal metabolome
Time frame: This analysis will be carried out at baseline and the end of each treatment period, entailing 4 measurements over an approximately 36 day period
Mass-spectrometry based analysis of the relative abundance of metabolites will be carried out on feces.
Intestinal permeability
Time frame: This analysis will be carried out at baseline and the end of each treatment period, entailing 4 measurements over an approximately 36 day period
Subjects will undergo lactulose-mannitol test to inform on gut permeability
2 secondary outcomes
Adherence to study diets
Time frame: Daily over two, 10-day periods
Amount of study diets consumed
Time frame: Daily over two, 10-day periods
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 19 Apr 2024.
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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.
David C Montrose, PhD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein isolate in people with Diet, Healthy, run by Stony Brook University 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 1 inclusion and 4 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 19 Apr 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 metabolome (time frame: This analysis will be carried out at baseline and the end of each treatment period, entailing 4 measurements over an approximately 36 day period). The study lists 2 primary outcomes in all. 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 19 Apr 2024.