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Protein Source on Plasma Amino Acid Concentrations In Older Adults (S55)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243395
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 17, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243395


Contacts
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Contact: Gavin Connolly, MA 989-331-2444 connolg@purdue.edu
Contact: Jan Green jkgreen@purdue.edu

Locations
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United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47905
Contact: Gavin Connolly, MA    989-331-2444    connolg@purdue.edu   
Contact: Jan Green       jkgreen@purdue.edu   
Principal Investigator: Wayne W Campbell, PhD         
Sponsors and Collaborators
Purdue University
Investigators
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Principal Investigator: Wayne W Campbell, PhD Purdue University

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Responsible Party: Wayne Campbell, Principal Investigator, Purdue University
ClinicalTrials.gov Identifier: NCT04243395    
Other Study ID Numbers: IRB-2019-354
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No