AgingNCT04064528
Effects of Age on Amino Acid Delivery to Tendon
A study testing Amino Acids in people with Aging, run by Purdue University at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2019to 1 Aug 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Aging
- Being tested
- Amino Acids
- Keywords
- amino acid, tendon, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino AcidsDietary supplement
10 g bolus of essential amino acids
| Study group | Role | What they receive |
|---|---|---|
| Young | Active comparator | Young adults will be given a 10 g oral bolus of amino acids. Receives: Dietary Supplement: Amino Acids |
| Older Adults | Experimental | Older adults will be given a 10 g oral bolus of amino acids. Receives: Dietary Supplement: Amino Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achilles Peritendinous Amino Acid Levels in young and older adults
Concentrations of amino acids will be measured from around the Achilles tendon
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 posted22 Aug 2019
- Study start6 Sep 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Non-randomised
- Intervention model
- Factorial
- Model description
- Young (21-30 years old) and older (60-75 years) adults will each receive an oral bolus of 10 g of essential amino acids.
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT04064528
- Sponsor's protocol ID
- 1904022075
- Status last verified
- Dec 2023
- First submitted
- 20 Aug 2019
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Age on Amino Acid Delivery to Tendon
- ClinicalTrials.gov ID
- NCT04064528
- Acronym / sponsor ID
- 1904022075
- Conditions
- Aging
- Keywords
- amino acid, tendon, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 22 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Young (21-30 years old) and older (60-75 years) adults will each receive an oral bolus of 10 g of essential amino acids.
| Arm | Type | Receives |
|---|---|---|
| Young | Active comparator | Dietary Supplement: Amino AcidsYoung adults will be given a 10 g oral bolus of amino acids. |
| Older Adults | Experimental | Dietary Supplement: Amino AcidsOlder adults will be given a 10 g oral bolus of amino acids. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- 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.
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 Acids10 g bolus of essential amino acids | Dietary supplement | Older Adults, Young |
Primary outcome
Achilles Peritendinous Amino Acid Levels in young and older adults
Time frame: 0-6 hours post consumption
Concentrations of amino acids will be measured from around the Achilles tendon
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 14 Dec 2023.
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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 Aging, 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 1 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 14 Dec 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 Amino Acid Levels in young and older adults (time frame: 0-6 hours post consumption). 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 14 Dec 2023.