Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Protein Source on Plasma Amino Acid Concentrations

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: NCT03649568
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University

Tracking Information
First Submitted Date  ICMJE August 24, 2018
First Posted Date  ICMJE August 28, 2018
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE August 24, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
Plasma amino acid concentrations [ Time Frame: 5 h ]
Plasma samples will be drawn at times 0, 30, 60, 120, 180, 240, and 300 min after the consumption of the trial meal.
Change History Complete list of historical versions of study NCT03649568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protein Source on Plasma Amino Acid Concentrations
Official Title  ICMJE 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
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 adults. Each participant will receive all four treatments.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Protein Deposition
Intervention  ICMJE
  • Other: Pork
    1 oz lean pork
  • Other: Egg
    1 large whole egg
  • Other: Black beans
    0.5 cups cooked black beans
  • Other: Almonds
    1 oz almonds
Study Arms  ICMJE
  • Experimental: Pork
    1 ounce lean pork
    Intervention: Other: Pork
  • Active Comparator: Egg
    1 large whole egg
    Intervention: Other: Egg
  • Experimental: Black beans
    0.5 cups cooked black beans
    Intervention: Other: Black beans
  • Experimental: Almonds
    1 ounce almonds
    Intervention: Other: Almonds
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Joshua L Hudson, PhD 7654948236 Hudson67@purdue.edu
Contact: Jan Green jkgreen@purdue.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03649568
Other Study ID Numbers  ICMJE 1804020520
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Wayne Campbell, Purdue University
Study Sponsor  ICMJE Purdue University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wayne W Campbell, PhD Purdue University
PRS Account Purdue University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP