TendinopathyNCT04067479
Can Amino Acid Supplementation Augment the Anabolic Response in Tendon After Exercise
A study testing Amino Acids in people with Tendinopathy, run by Purdue University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Amino Acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2017to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21-35 years or 60-80 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Tendinopathy
- Being tested
- Amino Acids
- Keywords
- tendon, amino acid, exercise
- Medical subject headings
- Tendinopathy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino AcidsDietary supplement
Oral bolus of essential amino acids
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Amino Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achilles peritendinous concentrations of pro-collagen
Peritendinous samples will be collected using microdialysis. Pro-collagen will be assessed using enzyme immunoassay kits
Measured: 0-6 hours post consumption
Amino Acid Levels
Achilles peritendinous amino acid concentrations will be assess using high performance liquid chromatography.
Measured: 0-6 hours post consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start9 May 2017
- Primary completion13 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chad C. Carroll, Purdue University
- Investigators
- Chad C Carroll, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067479
- Sponsor's protocol ID
- 1704019133
- Status last verified
- Apr 2023
- First submitted
- 20 Aug 2019
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Amino Acid Supplementation Augment the Anabolic Response in Tendon After Exercise
- ClinicalTrials.gov ID
- NCT04067479
- Acronym / sponsor ID
- 1704019133
- Conditions
- Tendinopathy
- Keywords
- tendon, amino acid, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young | Experimental | Dietary Supplement: Amino Acids21-30 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. |
| Older Adults | Experimental | Dietary Supplement: Amino AcidsInclusion/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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 21-35 years or 60-80 years old
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amino AcidsOral bolus of essential amino acids | Dietary supplement | Older Adults, Young |
Primary outcome
Achilles peritendinous concentrations of pro-collagen
Time frame: 0-6 hours post consumption
Peritendinous samples will be collected using microdialysis. Pro-collagen will be assessed using enzyme immunoassay kits
Amino Acid Levels
Time frame: 0-6 hours post consumption
Achilles peritendinous amino acid concentrations will be assess using high performance liquid chromatography.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad C Carroll, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acids in people with Tendinopathy, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achilles peritendinous concentrations of pro-collagen (time frame: 0-6 hours post consumption). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.