NCT04064528

Brief Summary

Dietary amino acid supplementation may provide an effective means to promote tendon injury recovery and enhance collagen synthesis. While most published research has been completed in animal models, research with young adults has shown that a leucine-rich whey isolate consumed during a chronic resistance training (RT) intervention resulted in greater gains (\~60%) in tendon CSA when compared to placebo. Leucine-rich diets have also improved tendon collagen content in rodents. Further, in our preliminary work utilizing microdialysis, we demonstrate that oral consumption of a leucine-rich amino acid beverage increased delivery of amino acids to tendons in young adults (21-30 years). However, whether aging alters the delivery of amino acids to tendons after oral consumption has not be investigated. In order to optimize amino acid dosing for chronic interventional studies, we wish to determine if aging influences amino acid concentration in the peritendinous (space around the tendon) space after oral consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 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

First Submitted

Initial submission to the registry

August 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

September 6, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

2.9 years

First QC Date

August 20, 2019

Last Update Submit

December 13, 2023

Conditions

Keywords

amino acidtendonaging

Outcome Measures

Primary Outcomes (1)

  • Achilles Peritendinous Amino Acid Levels in young and older adults

    Concentrations of amino acids will be measured from around the Achilles tendon

    0-6 hours post consumption

Study Arms (2)

Young

ACTIVE COMPARATOR

Young adults will be given a 10 g oral bolus of amino acids.

Dietary Supplement: Amino Acids

Older Adults

EXPERIMENTAL

Older adults will be given a 10 g oral bolus of amino acids.

Dietary Supplement: Amino Acids

Interventions

Amino AcidsDIETARY_SUPPLEMENT

10 g bolus of essential amino acids

Older AdultsYoung

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • body mass index \>35 kg•m-2, those on medications known to affect protein or collagen metabolism, e.g. acetaminophen, ibuprofen, or prescription cyclooxygenase inhibitors, previous history of tendinopathy, or diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Interventions

Amino Acids

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Chad C Carroll, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Model Details: Young (21-30 years old) and older (60-75 years) adults will each receive an oral bolus of 10 g of essential amino acids.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 22, 2019

Study Start

September 6, 2019

Primary Completion

August 1, 2022

Study Completion

August 1, 2023

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations