NCT03994198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
Last Updated

June 21, 2019

Status Verified

June 1, 2019

Enrollment Period

5 months

First QC Date

June 19, 2019

Last Update Submit

June 20, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Rate of myofibrillar muscle protein synthesis

    Rate of myofibrillar and protein synthesis (%/day)

    12 days

  • Rate of Sarcoplasmic muscle protein synthesis

    Rate of sarcoplasmic muscle protein synthesis (%/day)

    12 days

Secondary Outcomes (5)

  • Plasma amino acids

    1 x 1 hour

  • Sleep efficiency (%)

    12 days

  • Sleep fragmentation

    12 days

  • Wake after sleep onset (WASO) in minutes

    12 days

  • Total sleep time (min)

    12 days

Study Arms (2)

Alpha-lactalbumin

EXPERIMENTAL

Participants will consume 60 g of alphalactalbumin (fraction of whey protein) for 3 training days.

Dietary Supplement: Alpha-lactalbumin

Collagen peptides

ACTIVE COMPARATOR

Participants will consume 60 g of collagen peptides for 3 training days.

Dietary Supplement: Collagen peptides

Interventions

Alpha-lactalbuminDIETARY_SUPPLEMENT

A protein fraction of whey protein, higher in tryptophan

Alpha-lactalbumin
Collagen peptidesDIETARY_SUPPLEMENT

Collagen peptides from bovine sources

Collagen peptides

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivor Wynne Centre

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Interventions

Lactalbumin

Intervention Hierarchy (Ancestors)

AlbuminsProteinsAmino Acids, Peptides, and ProteinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary Proteins

Study Officials

  • Stuart Phillips, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized cross-over design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2019

First Posted

June 21, 2019

Study Start

November 1, 2017

Primary Completion

April 1, 2018

Study Completion

August 30, 2018

Last Updated

June 21, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations