- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03994198
Effect of Protein Quality During Overreaching in Trained Cyclists
Monitoring Exercise Performance and Mitigating Training Stress in Endurance-trained Cyclists
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Hamilton, Ontario, Canada, L8S 4L8
- Ivor Wynne Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alpha-lactalbumin
Participants will consume 60 g of alphalactalbumin (fraction of whey protein) for 3 training days.
|
A protein fraction of whey protein, higher in tryptophan
|
Active Comparator: Collagen peptides
Participants will consume 60 g of collagen peptides for 3 training days.
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Collagen peptides from bovine sources
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of myofibrillar muscle protein synthesis
Time Frame: 12 days
|
Rate of myofibrillar and protein synthesis (%/day)
|
12 days
|
Rate of Sarcoplasmic muscle protein synthesis
Time Frame: 12 days
|
Rate of sarcoplasmic muscle protein synthesis (%/day)
|
12 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma amino acids
Time Frame: 1 x 1 hour
|
Measurement of plasma amino acids 1 hour following ingestion of each beverage
|
1 x 1 hour
|
Sleep efficiency (%)
Time Frame: 12 days
|
Measured by Actigraphy
|
12 days
|
Sleep fragmentation
Time Frame: 12 days
|
Measured by Actigraphy
|
12 days
|
Wake after sleep onset (WASO) in minutes
Time Frame: 12 days
|
Measured by Actigraphy
|
12 days
|
Total sleep time (min)
Time Frame: 12 days
|
Measured by Actigraphy
|
12 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stuart Phillips, PhD, McMaster University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HIREB 3036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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