S55: Protein Source on Plasma Amino Acid Concentrations In Older Adults

Sponsor

Purdue University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04243395

Collaborator

(none)

Enrollment

Location

Arms

23.5

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Protein Deposition	Other: Pork Other: Egg Other: Black beans Other: Almonds	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Jan 17, 2020

Anticipated Primary Completion Date :

Nov 30, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pork 1 ounce lean pork	Other: Pork 1 oz lean pork
Experimental: Egg 1 large whole egg	Other: Egg 1 large whole egg
Experimental: Black beans 0.5 cups of cooked black beans	Other: Black beans 0.5 cups cooked black beans
Experimental: Almonds 0.5 ounce of whole almonds	Other: Almonds 0.5 oz almonds

Outcome Measures

Primary Outcome Measures

Plasma amino acid concentrations as measured by High Performance Liquid Chromatography (HPLC) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Purdue University	West Lafayette	Indiana	United States	47905

Sponsors and Collaborators

Purdue University

Investigators

Principal Investigator: Wayne W Campbell, PhD, Purdue University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wayne Campbell, Principal Investigator, Purdue University

ClinicalTrials.gov Identifier:

NCT04243395

Other Study ID Numbers:

IRB-2019-354

First Posted:

Jan 28, 2020

Last Update Posted:

Mar 24, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 24, 2021