Muscle Protein SynthesisNCT03994198
Effect of Protein Quality During Overreaching in Trained Cyclists
A study testing Alpha-lactalbumin and Collagen peptides in people with Muscle Protein Synthesis, run by McMaster University at 1 site in Canada.
Trial summary
Athletes frequently undertake periods of intensified training commonly referred to as "overreaching." These training periods acutely decrease performance, with the expectation that performance will rebound and improve after a short recovery. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Protein Synthesis
- What is being tested?
- Alpha-lactalbumin and Collagen peptides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2017to 30 Aug 2018
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smokers
- non-diabetic
- Participants had to be training regularly (performing aerobic exercise at least 4 times per week, including regular cycling exercise)
- Generally healthy
Who cannot join
- consuming excessive alcohol (>21 units per week)
- use of an investigational drug or nutraceutical in the previous 30 days
- dairy allergy
- history of significant loss or gain of body mass in the past 6 months (>2kg)
- regular use of non-steroidal anti-inflammatory drugs
- infectious disease, and/or the presence of any relevant disease (e.g., gastrointestinal, cardiovascular, neuromuscular, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Exercise Performance and Mitigating Training Stress in Endurance-trained Cyclists
Athletes frequently undertake periods of intensified training commonly referred to as "overreaching." These training periods acutely decrease performance, with the expectation that performance will rebound and improve after a short recovery. Yet, overreaching does not always improve performance and may be a precursor to overtraining syndrome, a long-term decrement in performance. A nutritional intervention focused on the adoption of 'best practices' for protein feeding (optimal timing, dose, and quality) could help reduce the stress of overreaching, reduce the likelihood of developing overtraining syndrome, and augment adaptations to intensified exercise. While the nutrition study is our main interest, the investigators first want to validate the measurement of exercise performance. Accordingly, this project consists of two related studies: (1) the assessment of short time trials for reliability and validity; and (2) the assessment of optimal protein feeding to decrease the stress of overreaching and improve outcomes following training.
Read the detailed description
Endurance-trained athletes frequently undergo periods of overreaching (increased training loads) to improve performance. In study 1, the investigators will determine whether 4-min and 20-min time trials are repeatable and whether they (individually or collectively) relate to 1-hour time trial performance. For Study 2, the investigators propose that proper nutrition (with a focus on the dose, timing, and quality of protein) can help mitigate the stress of overreaching, which will improve performance. Thus, the investigators will compare the effects of two diets that differ in terms of protein servings (dose, timing, quality). In Study 2, skeletal muscle biopsies will be collected to determine how dietary protein intervention impacts the quality and quantity of skeletal muscle mitochondria in response to intense training.
For study 1, the objective is to determine the reliability and validity of 4-min and 20-min time trial performance (mean power output).
For study 2, the objective is to (1) determine whether following an optimal protein diet during a period of intense training will, relative to a typical diet: (1) improve measures of exercise performance, (2) improve sleep quality, psychological wellbeing, and immune function, (3) improve the quality and quantity of skeletal muscle mitochondria.
Study 1 is a reliability and validity experiment designed to assess the key outcome measure in study 2.
Study 2 is a randomized, crossover study. Participants will, in a randomized order, complete both conditions, separated by a 4-day washout period.
- Conditions
- Muscle Protein Synthesis
- Being tested
- Alpha-lactalbumin, Collagen peptides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-lactalbuminDietary supplement
A protein fraction of whey protein, higher in tryptophan
Collagen peptidesDietary supplement
Collagen peptides from bovine sources
| Study group | Role | What they receive |
|---|---|---|
| Alpha-lactalbumin | Experimental | Participants will consume 60 g of alphalactalbumin (fraction of whey protein) for 3 training days. Receives: Dietary Supplement: Alpha-lactalbumin |
| Collagen peptides | Active comparator | Participants will consume 60 g of collagen peptides for 3 training days. Receives: Dietary Supplement: Collagen peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of myofibrillar muscle protein synthesis
Rate of myofibrillar and protein synthesis (%/day)
Measured: 12 days
Rate of Sarcoplasmic muscle protein synthesis
Rate of sarcoplasmic muscle protein synthesis (%/day)
Measured: 12 days
Secondary outcomes (5)
Plasma amino acids
Measurement of plasma amino acids 1 hour following ingestion of each beverage
Measured: 1 x 1 hour
Sleep efficiency (%)
Measured by Actigraphy
Measured: 12 days
Sleep fragmentation
Measured by Actigraphy
Measured: 12 days
Wake after sleep onset (WASO) in minutes
Measured by Actigraphy
Measured: 12 days
Total sleep time (min)
Measured by Actigraphy
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start1 Nov 2017
- Primary completion1 Apr 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Protein SynthesisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross-over design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart Phillips, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994198
- Sponsor's protocol ID
- HIREB 3036
- Status last verified
- Jun 2019
- First submitted
- 19 Jun 2019
- Last updated
- 21 Jun 2019
- 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 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Exercise Performance and Mitigating Training Stress in Endurance-trained Cyclists
- ClinicalTrials.gov ID
- NCT03994198
- Acronym / sponsor ID
- HIREB 3036
- Conditions
- Muscle Protein Synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 21 Jun 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.
Athletes frequently undertake periods of intensified training commonly referred to as "overreaching." These training periods acutely decrease performance, with the expectation that performance will rebound and improve after a short recovery. Yet, overreaching does not always improve performance and may be a precursor to overtraining syndrome, a long-term decrement in performance. A nutritional intervention focused on the adoption of 'best practices' for protein feeding (optimal timing, dose, and quality) could help reduce the stress of overreaching, reduce the likelihood of developing overtraining syndrome, and augment adaptations to intensified exercise. While the nutrition study is our main interest, the investigators first want to validate the measurement of exercise performance. Accordingly, this project consists of two related studies: (1) the assessment of short time trials for reliability and validity; and (2) the assessment of optimal protein feeding to decrease the stress of overreaching and improve outcomes following training.
Detailed description
Endurance-trained athletes frequently undergo periods of overreaching (increased training loads) to improve performance. In study 1, the investigators will determine whether 4-min and 20-min time trials are repeatable and whether they (individually or collectively) relate to 1-hour time trial performance. For Study 2, the investigators propose that proper nutrition (with a focus on the dose, timing, and quality of protein) can help mitigate the stress of overreaching, which will improve performance. Thus, the investigators will compare the effects of two diets that differ in terms of protein servings (dose, timing, quality). In Study 2, skeletal muscle biopsies will be collected to determine how dietary protein intervention impacts the quality and quantity of skeletal muscle mitochondria in response to intense training.
For study 1, the objective is to determine the reliability and validity of 4-min and 20-min time trial performance (mean power output).
For study 2, the objective is to (1) determine whether following an optimal protein diet during a period of intense training will, relative to a typical diet: (1) improve measures of exercise performance, (2) improve sleep quality, psychological wellbeing, and immune function, (3) improve the quality and quantity of skeletal muscle mitochondria.
Study 1 is a reliability and validity experiment designed to assess the key outcome measure in study 2.
Study 2 is a randomized, crossover study. Participants will, in a randomized order, complete both conditions, separated by a 4-day washout period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized cross-over design
| Arm | Type | Receives |
|---|---|---|
| Alpha-lactalbumin | Experimental | Dietary Supplement: Alpha-lactalbuminParticipants will consume 60 g of alphalactalbumin (fraction of whey protein) for 3 training days. |
| Collagen peptides | Active comparator | Dietary Supplement: Collagen peptidesParticipants will consume 60 g of collagen peptides for 3 training days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- non-smokers
- non-diabetic
- Participants had to be training regularly (performing aerobic exercise at least 4 times per week, including regular cycling exercise)
- Generally healthy
Key exclusion criteria (6 listed)
- consuming excessive alcohol (>21 units per week)
- use of an investigational drug or nutraceutical in the previous 30 days
- dairy allergy
- history of significant loss or gain of body mass in the past 6 months (>2kg)
- regular use of non-steroidal anti-inflammatory drugs
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 |
|---|---|---|
| Alpha-lactalbuminA protein fraction of whey protein, higher in tryptophan | Dietary supplement | Alpha-lactalbumin |
| Collagen peptidesCollagen peptides from bovine sources | Dietary supplement | Collagen peptides |
Primary outcome
Rate of myofibrillar muscle protein synthesis
Time frame: 12 days
Rate of myofibrillar and protein synthesis (%/day)
Rate of Sarcoplasmic muscle protein synthesis
Time frame: 12 days
Rate of sarcoplasmic muscle protein synthesis (%/day)
5 secondary outcomes
Plasma amino acids
Time frame: 1 x 1 hour
Sleep efficiency (%)
Time frame: 12 days
Sleep fragmentation
Time frame: 12 days
Wake after sleep onset (WASO) in minutes
Time frame: 12 days
Total sleep time (min)
Time frame: 12 days
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 21 Jun 2019.
- 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.
Stuart Phillips, PhD principal investigator
McMaster 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 Alpha-lactalbumin and Collagen peptides in people with Muscle Protein Synthesis, run by McMaster 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 4 inclusion and 6 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 21 Jun 2019. 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?
Rate of myofibrillar muscle protein synthesis (time frame: 12 days). 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 21 Jun 2019.