- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03649568
Protein Source on Plasma Amino Acid Concentrations
July 15, 2020 updated by: Wayne Campbell, Purdue University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
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
25 years to 39 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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.
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
|
|
ACTIVE_COMPARATOR: Egg
1 large whole egg
|
1 large whole egg
|
|
EXPERIMENTAL: Black beans
0.5 cups cooked black beans
|
0.5 cups cooked black beans
|
|
EXPERIMENTAL: Almonds
1 ounce almonds
|
1 oz almonds
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
August 24, 2018
Primary Completion (ACTUAL)
March 31, 2020
Study Completion (ACTUAL)
March 31, 2020
Study Registration Dates
First Submitted
August 24, 2018
First Submitted That Met QC Criteria
August 24, 2018
First Posted (ACTUAL)
August 28, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 16, 2020
Last Update Submitted That Met QC Criteria
July 15, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 1804020520
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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