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Can Amino Acid Supplementation Augment the Anabolic Response in Tendon After Exercise

Primary Purpose

Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amino Acids
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tendinopathy focused on measuring tendon, amino acid, exercise

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 21-35 years or 60-80 years old

Exclusion Criteria:

  • 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

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Young

Older Adults

Arm Description

21-30 year old men and women Inclusion/Exclusion Criteria 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). Age: 21-30 years Body mass index <35 kg•m-2, 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. Individuals with diabetes will be excluded. Diabetes is thought to change the structure of tendon. Individuals with a history of tendon pain will be excluded, as chronic tendon pain is associated with changes in the structure of tendon. Persons with allergies/sentivitiy to amino acids or ingedianet of Cystal Light will be excluded.

Inclusion/Exclusion Criteria 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). Age: 60-75 years Body mass index <35 kg•m-2 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. Individuals with diabetes will be excluded. Diabetes is thought to change the structure of tendon. Individuals with a history of tendon pain will be excluded, as chronic tendon pain is associated with changes in the structure of tendon. Persons with allergies/sentivitiy to amino acids or ingedianet of Cystal Light will be excluded.

Outcomes

Primary Outcome Measures

Achilles peritendinous concentrations of pro-collagen
Peritendinous samples will be collected using microdialysis. Pro-collagen will be assessed using enzyme immunoassay kits
Amino Acid Levels
Achilles peritendinous amino acid concentrations will be assess using high performance liquid chromatography.

Secondary Outcome Measures

Full Information

First Posted
August 20, 2019
Last Updated
April 9, 2023
Sponsor
Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT04067479
Brief Title
Can Amino Acid Supplementation Augment the Anabolic Response in Tendon After Exercise
Official Title
Can Amino Acid Supplementation Augment the Anabolic Response in Tendon After Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 9, 2017 (Actual)
Primary Completion Date
December 13, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Tendon pain is a common complaint in older adults. The mechanisms contributing to the large number of tendon problems in older adults are not known. It has been shown that tendon cross-sectional area (CSA) is reduced with aging concurrent with a significant loss of tendon collagen. Exercise is used to reverse the loss of muscle mass with aging but surprisingly exercise interventions designed to reduce tendon problems in older people are relatively unexplored. In young adults, exercise stimulates tendon collagen synthesis and enhances the production of growth factors, which stimulate tendon collagen production. It is presumed that exercise-induced increase in collagen synthesis contributes to the increase in tendon stiffness and CSA noted in young adults after chronic resistance exercise (RE). In contrast, our preliminary work indicates that RE is not effective at reducing the effects of aging on tendon. The investigators have demonstrated that 12-weeks of RE does not lead to increases in tendon CSA or stiffness, even when skeletal muscle mass and strength are greatly enhanced. To prevent tendon injury, greater tendon CSA and stiffness aid in withstanding the force generated by trained skeletal muscle. Greater CSA and stiffness also optimize force transfer through tendon to maximize musculoskeletal function. Our findings indicate that RE is not an optimal intervention for reversing age-related changes in tendon properties. Novel interventions are clearly needed that will enhance collagen synthesis leading to an increase in tendon stiffness and CSA while also improving skeletal muscle mass and strength in older individuals. This study will evaluate the effectiveness of various methods for stimulating tendon collagen synthesis during a bout of acute exercise. Specifically, the investigators propose two approaches to this problem. An acute bout of cycling exercise will enhance the release of growth factors leading to a larger increase in tendon collagen synthesis. A bolus of amino acids given orally will increase the release of key stimulators of tendon collagen synthesis leading to enhanced collagen synthesis after acute exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
tendon, amino acid, exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Young
Arm Type
Experimental
Arm Description
21-30 year old men and women Inclusion/Exclusion Criteria 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). Age: 21-30 years Body mass index <35 kg•m-2, 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. Individuals with diabetes will be excluded. Diabetes is thought to change the structure of tendon. Individuals with a history of tendon pain will be excluded, as chronic tendon pain is associated with changes in the structure of tendon. Persons with allergies/sentivitiy to amino acids or ingedianet of Cystal Light will be excluded.
Arm Title
Older Adults
Arm Type
Experimental
Arm Description
Inclusion/Exclusion Criteria 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). Age: 60-75 years Body mass index <35 kg•m-2 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. Individuals with diabetes will be excluded. Diabetes is thought to change the structure of tendon. Individuals with a history of tendon pain will be excluded, as chronic tendon pain is associated with changes in the structure of tendon. Persons with allergies/sentivitiy to amino acids or ingedianet of Cystal Light will be excluded.
Intervention Type
Dietary Supplement
Intervention Name(s)
Amino Acids
Intervention Description
Oral bolus of essential amino acids
Primary Outcome Measure Information:
Title
Achilles peritendinous concentrations of pro-collagen
Description
Peritendinous samples will be collected using microdialysis. Pro-collagen will be assessed using enzyme immunoassay kits
Time Frame
0-6 hours post consumption
Title
Amino Acid Levels
Description
Achilles peritendinous amino acid concentrations will be assess using high performance liquid chromatography.
Time Frame
0-6 hours post consumption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 21-35 years or 60-80 years old Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad C Carroll, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Can Amino Acid Supplementation Augment the Anabolic Response in Tendon After Exercise

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