NCT04067479

Brief Summary

The goal of this study is to determine if an oral provision of amino acids will enhance exercise-induced increases in markers of Achilles tendon collagen production.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

5.6 years

First QC Date

August 20, 2019

Last Update Submit

April 9, 2023

Conditions

Keywords

tendonamino acidexercise

Outcome Measures

Primary Outcomes (2)

  • Achilles peritendinous concentrations of pro-collagen

    Peritendinous samples will be collected using microdialysis. Pro-collagen will be assessed using enzyme immunoassay kits

    0-6 hours post consumption

  • Amino Acid Levels

    Achilles peritendinous amino acid concentrations will be assess using high performance liquid chromatography.

    0-6 hours post consumption

Study Arms (2)

Young

EXPERIMENTAL

21-30 year old men and women Inclusion/Exclusion Criteria 1. All subjects will be sedentary or recreationally active (sedentary: one day or less per week of aerobic or resistance exercise for at least a year or recreationally active: not training for competitive events). 2. Age: 21-30 years 3. Body mass index \<35 kg•m-2, 4. Chronic users of medications such as acetaminophen, ibuprofen, or prescription cyclooxygenase inhibitors will be excluded as these medications have been shown to alter tendon physiology. 5. Individuals with diabetes will be excluded. Diabetes is thought to change the structure of tendon. 6. Individuals with a history of tendon pain will be excluded, as chronic tendon pain is associated with changes in the structure of tendon. 7. Persons with allergies/sentivitiy to amino acids or ingedianet of Cystal Light will be excluded.

Dietary Supplement: Amino Acids

Older Adults

EXPERIMENTAL

Inclusion/Exclusion Criteria 1. All subjects will be sedentary or recreationally active (sedentary: one day or less per week of aerobic or resistance exercise for at least a year or recreationally active: not training for competitive events). 2. Age: 60-75 years 3. Body mass index \<35 kg•m-2 4. Chronic users of medications such as acetaminophen, ibuprofen, or prescription cyclooxygenase inhibitors will be excluded as these medications have been shown to alter tendon physiology. 5. Individuals with diabetes will be excluded. Diabetes is thought to change the structure of tendon. 6. Individuals with a history of tendon pain will be excluded, as chronic tendon pain is associated with changes in the structure of tendon. 7. Persons with allergies/sentivitiy to amino acids or ingedianet of Cystal Light will be excluded.

Dietary Supplement: Amino Acids

Interventions

Amino AcidsDIETARY_SUPPLEMENT

Oral bolus of essential amino acids

Older AdultsYoung

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or 60-80 years old

You may not qualify if:

  • diabetes
  • BMI\>35
  • acute illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, metabolic disorders, arthritis, or a history of neuromuscular problems.
  • chronic pain medication users
  • alcoholism
  • competitive athletes
  • pregnant women will be excluded
  • Individuals with specific allergies to amino acids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

TendinopathyMotor Activity

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesBehavior

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
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 26, 2019

Study Start

May 9, 2017

Primary Completion

December 13, 2022

Study Completion

December 20, 2022

Last Updated

April 11, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations