- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04243395
Protein Source on Plasma Amino Acid Concentrations In Older Adults (S55)
September 26, 2022 updated by: Wayne Campbell, Purdue University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47905
- Purdue University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Pork
1 ounce lean pork
|
1 oz lean pork
|
EXPERIMENTAL: Egg
1 large whole egg
|
1 large whole egg
|
EXPERIMENTAL: Black beans
0.5 cups of cooked black beans
|
0.5 cups cooked black beans
|
EXPERIMENTAL: Almonds
0.5 ounce of whole almonds
|
0.5 oz almonds
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 17, 2020
Primary Completion (ACTUAL)
November 30, 2021
Study Completion (ACTUAL)
December 31, 2021
Study Registration Dates
First Submitted
January 18, 2020
First Submitted That Met QC Criteria
January 24, 2020
First Posted (ACTUAL)
January 28, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 28, 2022
Last Update Submitted That Met QC Criteria
September 26, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- IRB-2019-354
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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