NCT04243395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 18, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

1.9 years

First QC Date

January 18, 2020

Last Update Submit

September 26, 2022

Conditions

Protein Deposition

Outcome Measures

Primary Outcomes (1)

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

    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

Study Arms (4)

Pork

EXPERIMENTAL

1 ounce lean pork

Other: Pork

Egg

EXPERIMENTAL

1 large whole egg

Other: Egg

Black beans

EXPERIMENTAL

0.5 cups of cooked black beans

Other: Black beans

Almonds

EXPERIMENTAL

0.5 ounce of whole almonds

Other: Almonds

Interventions

PorkOTHER

1 oz lean pork

Pork
EggOTHER

1 large whole egg

Egg
Black beansOTHER

0.5 cups cooked black beans

Black beans
AlmondsOTHER

0.5 oz almonds

Almonds

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47905, United States

Location

MeSH Terms

Interventions

Pork MeatEggs

Intervention Hierarchy (Ancestors)

Red MeatMeatFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Wayne W Campbell, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2020

First Posted

January 28, 2020

Study Start

January 17, 2020

Primary Completion

November 30, 2021

Study Completion

December 31, 2021

Last Updated

September 28, 2022

Record last verified: 2022-09

Locations

US(1)