HealthyNCT06431334
Protein Requirements Amongst Male Masters-Level Athletes Following a Cycling Exercise Bout as Determined by the Indicator Amino Acid Oxidation Technique
A study testing Amino Acid Intake in people with Healthy and Increased Metabolic Requirements, run by McGill University at 1 site in Canada.
Trial summary
Masters level cyclists are a population above the age of 35 years who frequently participate in prolonged as well as heavy-volume training. Like most endurance-trained athletes, a greater recommended dietary allowance (RDA) for protein of 1.2-1.4 g/kg/bw is suggested. Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Increased Metabolic Requirements, Dietary Reference Intakes
- What is being tested?
- Amino Acid Intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jun 2024to 8 Oct 2026
- 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 65 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 18.5< BMI <35 kg/m^2
- Overtly healthy masters level cyclists ≥65 years
- Masters level cyclist training (>4 days per week; ~100 km per week)
- Body mass stable over previous 6-months
- Availability for multiple metabolic trials (~7 trials)
- Ability to travel to and from laboratory facility
Who cannot join
- Recent history of weight loss or weight gain (>5% body weight)
- Uncontrolled hypertension
- ≥2 chronic diseases (e.g. diabetes, osteoporosis, dyslipidemia)
- Acute illness that could affect protein metabolism (HIV, renal dysfunction, influenza)
- Currently using anti-inflammatory medications
- Inability to adhere to study protocol (i.e., alcohol, caffeine, dietary restrictions)
Show all 9Show fewer
- Regular tobacco user
- Illicit drug use
- Habitually ingesting ≥3 g/kg/bw
Trial locations and contacts
1 site in 1 country.
About this study
Masters level cyclists are a population above the age of 35 years who frequently participate in prolonged as well as heavy-volume training. Like most endurance-trained athletes, a greater recommended dietary allowance (RDA) for protein of 1.2-1.4 g/kg/bw is suggested.
Dietary protein intake is vital for maximizing the benefits of training and ensuring optimal recovery. Dietary recommendations traditionally have been determined through nitrogen balance techniques, however, recent research indicates how this method is potentially underestimating protein requirements. Therefore, there is a need to reassess current dietary recommendations in order to meet the demands of physical activity for highly active populations.
Read more
Recent efforts to understand protein requirements during rest and following exercise have been completed using the indicator amino acid technique (IAAO). This non-invasive method is reported to provide a robust measure of protein requirements. However, there is limited work in older (≥60 years) active populations.
The purpose of this study is to measure the protein requirements in master cyclists, following an endurance training session, using the non-invasive IAAO technique.
- Being tested
- Amino Acid Intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid IntakeDietary supplement
Amino acid intakes will vary between 0.2 to 2.8 g/kg/d
| Study group | Role | What they receive |
|---|---|---|
| Masters Level Cyclists | Experimental | Participants are to be randomly assigned varying levels of amino acid intakes ranging between 0.2 to 2.8 g/kg/d Receives: Dietary Supplement: Amino Acid Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
13CO2 Excretion
Measured by continuous-flow isotope ratio mass spectrometry
Measured: 7-weeks
Secondary outcomes (1)
L[13C]phenylalanine Oxidation
Measured by gas chromatography-mass spectrometry
Measured: 7-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start21 Jun 2024
- Primary completion8 Oct 2026
- Study completion8 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler Churchward-Venne, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431334
- Sponsor's protocol ID
- A06-M25-23A
- Status last verified
- Oct 2026
- First submitted
- 22 May 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Requirements Amongst Male Masters-Level Athletes Following a Cycling Exercise Bout as Determined by the Indicator Amino Acid Oxidation Technique
- ClinicalTrials.gov ID
- NCT06431334
- Acronym / sponsor ID
- A06-M25-23A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 8 Oct 2026 (actual)
- Study completion
- 8 Oct 2026 (actual)
- First posted
- 28 May 2024 (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.
Masters level cyclists are a population above the age of 35 years who frequently participate in prolonged as well as heavy-volume training. Like most endurance-trained athletes, a greater recommended dietary allowance (RDA) for protein of 1.2-1.4 g/kg/bw is suggested.
Dietary protein intake is vital for maximizing the benefits of training and ensuring optimal recovery. Dietary recommendations traditionally have been determined through nitrogen balance techniques, however, recent research indicates how this method is potentially underestimating protein requirements. Therefore, there is a need to reassess current dietary recommendations in order to meet the demands of physical activity for highly active populations.
Recent efforts to understand protein requirements during rest and following exercise have been completed using the indicator amino acid technique (IAAO). This non-invasive method is reported to provide a robust measure of protein requirements. However, there is limited work in older (≥60 years) active populations.
The purpose of this study is to measure the protein requirements in master cyclists, following an endurance training session, using the non-invasive IAAO technique.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Masters Level Cyclists | Experimental | Dietary Supplement: Amino Acid IntakeParticipants are to be randomly assigned varying levels of amino acid intakes ranging between 0.2 to 2.8 g/kg/d |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 18.5< BMI <35 kg/m^2
- Overtly healthy masters level cyclists ≥65 years
- Masters level cyclist training (>4 days per week; ~100 km per week)
- Body mass stable over previous 6-months
- Availability for multiple metabolic trials (~7 trials)
Key exclusion criteria (9 listed)
- Recent history of weight loss or weight gain (>5% body weight)
- Uncontrolled hypertension
- ≥2 chronic diseases (e.g. diabetes, osteoporosis, dyslipidemia)
- Acute illness that could affect protein metabolism (HIV, renal dysfunction, influenza)
- Currently using anti-inflammatory medications
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 Acid IntakeAmino acid intakes will vary between 0.2 to 2.8 g/kg/d | Dietary supplement | Masters Level Cyclists |
Primary outcome
13CO2 Excretion
Time frame: 7-weeks
Measured by continuous-flow isotope ratio mass spectrometry
1 secondary outcome
L[13C]phenylalanine Oxidation
Time frame: 7-weeks
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 15 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acid Intake in people with Healthy and Increased Metabolic Requirements, run by McGill University at 1 site in Canada.
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 6 inclusion and 9 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 15 Oct 2026. 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 Canada. 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?
13CO2 Excretion (time frame: 7-weeks). 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 15 Oct 2026.