Protein DepositionNCT03649568
Protein Source on Plasma Amino Acid Concentrations
A study testing Pork, Egg and Black beans in people with Protein Deposition, run by Purdue University at 1 site in United States.
Trial summary
This study will determine the effect of the same ounce-equivalents of fresh pork versus nuts, beans, and eggs on postprandial plasma essential amino acid availability in adults. Each participant will receive all four treatments. Read more about this study
- Who is it for?
- Ages 25 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Deposition
- What is being tested?
- Pork, Egg and Black beans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2018to 31 Mar 2020
- 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 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Age 25-39
- BMI 25-35 kg∙m-2
- Weight stable (± 4.5 kg) 3 months pre-study
- Not acutely ill
- Not diabetic
Show all 10Show fewer
- Not pregnant or lactating
- Not currently (or within 3 months pre-study) following a vigorous exercise regimen
- Non-smoking
- Willing to consume study foods and travel to testing facilities.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Consuming Ounce Equivalent Portions of Fresh Pork Versus Nuts, Beans, and Eggs as Defined by the Dietary Guidelines for Americans on Essential Amino Acid Substrate Availability for Protein Anabolism
This study will determine the effect of the same ounce-equivalents of fresh pork versus nuts, beans, and eggs on postprandial plasma essential amino acid availability in adults. Each participant will receive all four treatments.
Read the detailed description
The 2015-2020 Dietary Guidelines for Americans stipulates how much Protein Foods should be consumed per day and per week as part of a Healthy U.S.-Style Eating Pattern. The predominant protein sources include lean meats, poultry, and eggs, however, nuts, seeds, and soy products are also included. Ounce-equivalents (oz-eq) are used as a standard unit of measure to compare animal to non-animal protein sources. One oz-eq of lean meat (1 oz) is equal to 0.5 oz of nuts (1 oz-eq), 0.25 cups (1 oz-eq) of beans, and one whole egg (1 oz-eq). One limitation of this unit of measure is that the protein quantity and quality of the foods are not considered. For example, 1 oz-eq of pork loin contains ~7 g of dietary protein whereas 1 oz-eq of almonds contains 3 g of protein. Consequently, consuming an oz-eq portion of protein foods from different sources could have different effects on the anabolic response to feeding. The purpose of this study is to assess the effect of consuming ounce equivalent portions of fresh pork versus nuts, beans, and eggs on essential amino acid substrate availability for protein anabolism. While it would seem intuitive that this research would show that higher protein intakes from pork and egg will lead to higher plasma essential amino acid responses, this research is paramount to addressing the shortcoming of using oz-eq to achieve the Dietary Guidelines for Americans recommendations for Protein Foods. This research will serve as an important resource for future Dietary Guidelines Advisory Committees to reevaluate the appropriateness of equating animal- and plant-based Protein Foods on the current ounce-equivalent basis.
- Conditions
- Protein Deposition
- Being tested
- Pork, Egg, Black beans, Almonds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PorkOther
1 oz lean pork
EggOther
1 large whole egg
Black beansOther
0.5 cups cooked black beans
AlmondsOther
1 oz almonds
| Study group | Role | What they receive |
|---|---|---|
| Pork | Experimental | 1 ounce lean pork Receives: Other: Pork |
| Egg | Active comparator | 1 large whole egg Receives: Other: Egg |
| Black beans | Experimental | 0.5 cups cooked black beans Receives: Other: Black beans |
| Almonds | Experimental | 1 ounce almonds Receives: Other: Almonds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amino acid concentrations
Plasma samples will be drawn at times 0, 30, 60, 120, 180, 240, and 300 minutes after the consumption of the trial meal.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start24 Aug 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein DepositionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne W Campbell, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649568
- Sponsor's protocol ID
- 1804020520
- Status last verified
- Jul 2020
- First submitted
- 24 Aug 2018
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consuming Ounce Equivalent Portions of Fresh Pork Versus Nuts, Beans, and Eggs as Defined by the Dietary Guidelines for Americans on Essential Amino Acid Substrate Availability for Protein Anabolism
- ClinicalTrials.gov ID
- NCT03649568
- Acronym / sponsor ID
- 1804020520
- Conditions
- Protein Deposition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 28 Aug 2018 (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 the same ounce-equivalents of fresh pork versus nuts, beans, and eggs on postprandial plasma essential amino acid availability in adults. Each participant will receive all four treatments.
Detailed description
The 2015-2020 Dietary Guidelines for Americans stipulates how much Protein Foods should be consumed per day and per week as part of a Healthy U.S.-Style Eating Pattern. The predominant protein sources include lean meats, poultry, and eggs, however, nuts, seeds, and soy products are also included. Ounce-equivalents (oz-eq) are used as a standard unit of measure to compare animal to non-animal protein sources. One oz-eq of lean meat (1 oz) is equal to 0.5 oz of nuts (1 oz-eq), 0.25 cups (1 oz-eq) of beans, and one whole egg (1 oz-eq). One limitation of this unit of measure is that the protein quantity and quality of the foods are not considered. For example, 1 oz-eq of pork loin contains ~7 g of dietary protein whereas 1 oz-eq of almonds contains 3 g of protein. Consequently, consuming an oz-eq portion of protein foods from different sources could have different effects on the anabolic response to feeding. The purpose of this study is to assess the effect of consuming ounce equivalent portions of fresh pork versus nuts, beans, and eggs on essential amino acid substrate availability for protein anabolism. While it would seem intuitive that this research would show that higher protein intakes from pork and egg will lead to higher plasma essential amino acid responses, this research is paramount to addressing the shortcoming of using oz-eq to achieve the Dietary Guidelines for Americans recommendations for Protein Foods. This research will serve as an important resource for future Dietary Guidelines Advisory Committees to reevaluate the appropriateness of equating animal- and plant-based Protein Foods on the current ounce-equivalent basis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pork | Experimental | Other: Pork1 ounce lean pork |
| Egg | Active comparator | Other: Egg1 large whole egg |
| Black beans | Experimental | Other: Black beans0.5 cups cooked black beans |
| Almonds | Experimental | Other: Almonds1 ounce almonds |
Who may qualify
- Ages
- 25 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female
- Age 25-39
- BMI 25-35 kg∙m-2
- Weight stable (± 4.5 kg) 3 months pre-study
- Not acutely ill
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Pork1 oz lean pork | Other | Pork |
| Egg1 large whole egg | Other | Egg |
| Black beans0.5 cups cooked black beans | Other | Black beans |
| Almonds1 oz almonds | Other | Almonds |
Primary outcome
Plasma amino acid concentrations
Time frame: 5 hours
Plasma samples will be drawn at times 0, 30, 60, 120, 180, 240, and 300 minutes after the consumption of the trial meal.
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 16 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Wayne W Campbell, PhD principal investigator
Purdue 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 Pork, Egg and Black beans in people with Protein Deposition, run by Purdue 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 10 inclusion and 0 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 16 Jul 2020. 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?
Plasma amino acid concentrations (time frame: 5 hours). 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 16 Jul 2020.