COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Effect of Protein Quality During Overreaching in Trained Cyclists

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03994198
Recruitment Status : Completed
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Information provided by (Responsible Party):
Stuart Phillips, McMaster University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Muscle Protein Synthesis Dietary Supplement: Alpha-lactalbumin Dietary Supplement: Collagen peptides Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized cross-over design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants and the investigators will be blinded the the supplement type, only the LPI will have the codes to decipher the supplement type. Supplements are referred to as A and B.
Primary Purpose: Other
Official Title: Monitoring Exercise Performance and Mitigating Training Stress in Endurance-trained Cyclists
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: Alpha-lactalbumin
Participants will consume 60 g of alphalactalbumin (fraction of whey protein) for 3 training days.
Dietary Supplement: Alpha-lactalbumin
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.
Dietary Supplement: Collagen peptides
Collagen peptides from bovine sources

Primary Outcome Measures :
  1. Rate of myofibrillar muscle protein synthesis [ Time Frame: 12 days ]
    Rate of myofibrillar and protein synthesis (%/day)

  2. Rate of Sarcoplasmic muscle protein synthesis [ Time Frame: 12 days ]
    Rate of sarcoplasmic muscle protein synthesis (%/day)

Secondary Outcome Measures :
  1. Plasma amino acids [ Time Frame: 1 x 1 hour ]
    Measurement of plasma amino acids 1 hour following ingestion of each beverage

  2. Sleep efficiency (%) [ Time Frame: 12 days ]
    Measured by Actigraphy

  3. Sleep fragmentation [ Time Frame: 12 days ]
    Measured by Actigraphy

  4. Wake after sleep onset (WASO) in minutes [ Time Frame: 12 days ]
    Measured by Actigraphy

  5. Total sleep time (min) [ Time Frame: 12 days ]
    Measured by Actigraphy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03994198

Layout table for location information
Canada, Ontario
Ivor Wynne Centre
Hamilton, Ontario, Canada, L8S 4L8
Sponsors and Collaborators
McMaster University
Layout table for investigator information
Principal Investigator: Stuart Phillips, PhD McMaster University
Layout table for additonal information
Responsible Party: Stuart Phillips, Professor, McMaster University Identifier: NCT03994198    
Other Study ID Numbers: HIREB 3036
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No