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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03994198
Other study ID # HIREB 3036
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date August 30, 2018

Study information

Verified date June 2019
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date August 30, 2018
Est. primary completion date April 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Alpha-lactalbumin
A protein fraction of whey protein, higher in tryptophan
Collagen peptides
Collagen peptides from bovine sources

Locations

Country Name City State
Canada Ivor Wynne Centre Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of myofibrillar muscle protein synthesis Rate of myofibrillar and protein synthesis (%/day) 12 days
Primary Rate of Sarcoplasmic muscle protein synthesis Rate of sarcoplasmic muscle protein synthesis (%/day) 12 days
Secondary Plasma amino acids Measurement of plasma amino acids 1 hour following ingestion of each beverage 1 x 1 hour
Secondary Sleep efficiency (%) Measured by Actigraphy 12 days
Secondary Sleep fragmentation Measured by Actigraphy 12 days
Secondary Wake after sleep onset (WASO) in minutes Measured by Actigraphy 12 days
Secondary Total sleep time (min) Measured by Actigraphy 12 days
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