Protein DepositionS55NCT04243395
Protein Source on Plasma Amino Acid Concentrations In Older Adults
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 older adults. Each participant will receive all four treatments. Read more about this study
- Who is it for?
- Ages 55 to 75 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
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2020to 31 Dec 2021
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- Age 55-75
- BMI 20-35 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects 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 in Older Adults
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 older adults. Each participant will receive all four treatments.
Read the detailed description
The 2015-2020 Dietary Guidelines for Americans (DGA) recommends how much protein-rich foods should be consumed as part of Healthy Eating Patterns. The predominant protein sources include lean meats, poultry, and eggs, along with nuts, seeds, and soy products (dairy is a separate category). Ounce-equivalent (oz-eq) is used as a standard unit of measure among these protein sources. One whole egg (1 oz-eq) is equal to 0.5 oz of nuts (1 oz-eq), 0.25 c (1 oz-eq) of beans, and 1 oz of lean meat (1 oz-eq). Importantly, protein quantity and quality of the foods are not considered. Consequently, consuming an oz-eq of protein foods from different sources may have different effects on an individuals' digestion, absorption, and use of the amino acids contained in proteins to build new proteins in their body (an anabolic response to feeding). Also importantly, while the current Recommended Dietary Allowance for protein (0.8 g total protein/kg/d) does not take into account the sources of protein consumed, these sources have varied essential amino acid patterns. The purpose of this study is to expand on a recent study assessing the effect of consuming ounce-equivalents of eggs versus pork, nuts, and beans on essential amino acid (EAA) substrate availability for protein anabolism in younger adults to include a cohort of older adults. Findings from this current research will allow direct comparisons of postprandial EAA substrate availability between different protein-rich food sources in a cohort of older adults (primary outcome). Subsequently, investigating postprandial responses of the same ounce-equivalents of fresh pork versus nuts, beans, and eggs on postprandial plasma essential amino acid availability in older adults will also allow for a comparison between the younger (from a study started prior to this one and still currently ongoing investigating the effect of the same ounce-equivalents of fresh pork versus nuts, beans, and eggs on postprandial plasma essential amino acid availability in adults) and older adult cohorts response to consuming different protein-rich foods (secondary outcome). This research will serve as an important resource for future DGA Committees to assess whether 'protein-ounce-equivalents' of varied protein-rich foods provide equivalent EAA substrate to promote postprandial protein synthesis in older adults, in support of dietary protein intake recommendations for younger and older adults.
- 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
0.5 oz almonds
| Study group | Role | What they receive |
|---|---|---|
| Pork | Experimental | 1 ounce lean pork Receives: Other: Pork |
| Egg | Experimental | 1 large whole egg Receives: Other: Egg |
| Black beans | Experimental | 0.5 cups of cooked black beans Receives: Other: Black beans |
| Almonds | Experimental | 0.5 ounce of whole 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 as measured by High Performance Liquid Chromatography (HPLC)
Plasma samples will be drawn at times 0, 30, 60, 120, 180, 240, and 300 minutes after the consumption of the trial meal.
The amino acids that will be assessed are alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine.
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 Jan 2020
- Study start17 Jan 2020
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
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
- 25 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
- NCT04243395
- Sponsor's protocol ID
- IRB-2019-354
- Acronym
- S55
- Status last verified
- Sep 2022
- First submitted
- 18 Jan 2020
- Last updated
- 28 Sep 2022
- 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 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects 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 in Older Adults
- ClinicalTrials.gov ID
- NCT04243395
- Acronym / sponsor ID
- S55 / IRB-2019-354
- Conditions
- Protein Deposition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Jan 2020 (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 older adults. Each participant will receive all four treatments.
Detailed description
The 2015-2020 Dietary Guidelines for Americans (DGA) recommends how much protein-rich foods should be consumed as part of Healthy Eating Patterns. The predominant protein sources include lean meats, poultry, and eggs, along with nuts, seeds, and soy products (dairy is a separate category). Ounce-equivalent (oz-eq) is used as a standard unit of measure among these protein sources. One whole egg (1 oz-eq) is equal to 0.5 oz of nuts (1 oz-eq), 0.25 c (1 oz-eq) of beans, and 1 oz of lean meat (1 oz-eq). Importantly, protein quantity and quality of the foods are not considered. Consequently, consuming an oz-eq of protein foods from different sources may have different effects on an individuals' digestion, absorption, and use of the amino acids contained in proteins to build new proteins in their body (an anabolic response to feeding). Also importantly, while the current Recommended Dietary Allowance for protein (0.8 g total protein/kg/d) does not take into account the sources of protein consumed, these sources have varied essential amino acid patterns. The purpose of this study is to expand on a recent study assessing the effect of consuming ounce-equivalents of eggs versus pork, nuts, and beans on essential amino acid (EAA) substrate availability for protein anabolism in younger adults to include a cohort of older adults. Findings from this current research will allow direct comparisons of postprandial EAA substrate availability between different protein-rich food sources in a cohort of older adults (primary outcome). Subsequently, investigating postprandial responses of the same ounce-equivalents of fresh pork versus nuts, beans, and eggs on postprandial plasma essential amino acid availability in older adults will also allow for a comparison between the younger (from a study started prior to this one and still currently ongoing investigating the effect of the same ounce-equivalents of fresh pork versus nuts, beans, and eggs on postprandial plasma essential amino acid availability in adults) and older adult cohorts response to consuming different protein-rich foods (secondary outcome). This research will serve as an important resource for future DGA Committees to assess whether 'protein-ounce-equivalents' of varied protein-rich foods provide equivalent EAA substrate to promote postprandial protein synthesis in older adults, in support of dietary protein intake recommendations for younger and older adults.
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 | Experimental | Other: Egg1 large whole egg |
| Black beans | Experimental | Other: Black beans0.5 cups of cooked black beans |
| Almonds | Experimental | Other: Almonds0.5 ounce of whole almonds |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female
- Age 55-75
- BMI 20-35 kg∙m-2
- Weight stable (± 4.5 kg) 3 months pre-study
- Not acutely ill
Key exclusion criteria (1 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 |
| Almonds0.5 oz almonds | Other | Almonds |
Primary outcome
Plasma amino acid concentrations as measured by High Performance Liquid Chromatography (HPLC)
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. The amino acids that will be assessed are alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine.
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 28 Sep 2022.
Related trials for Protein Deposition
Active, not recruitingPhase 3
Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma
Light Chain Deposition Disease, Smoldering Multiple Myeloma
RecruitingObservational study
A Study of Retinal Imaging to Detect Abnormal Protein Deposits Associated With Alzheimer's Disease
Cognitive Dysfunction, Memory Disorders
RecruitingObservational study
A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH
Multiple Myeloma, Amyloidosis
RecruitingObservational study
Registry for Adults With Plasma Cell Disorders (PCD's)
Multiple Myeloma, Amyloidosis
RecruitingObservational study
Brain Characterization of Amyloid Protein and Glucose Metabolism of ALFA Project Participants
Alzheimer's Disease
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 1 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 28 Sep 2022. 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 as measured by High Performance Liquid Chromatography (HPLC) (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 28 Sep 2022.