NCT03063346

Brief Summary

Overtraining is a real problem for (semi-)professional athletes. Overtraining is often caused by the bodies' lack of ability to recover between training. In addition, during high intensity training reactive oxygen species are formed up to 20 fold compared to resting values. This causes increased muscle tissue damage after intense exercise, which slows down recovery. Improving recovery may increase an athlete's ability to reach higher training volumes resulting in establishing a higher performance plateau. It is known that hydrolyzed proteins have a positive effect on muscle protein synthesis due to its faster absorption rate. Therefore, it is hypothesized that a known protein hydrolysate may have positive effects on strength recovery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2017

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2017

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

February 2, 2017

Last Update Submit

March 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle strength recovery

    difference in peak force between the exhaustion challenge and the recovery challenge, measured with a linear encoder during a squat exercise

    4 weeks

Secondary Outcomes (4)

  • Blood lactate buildup

    4 weeks

  • Body composition

    4 weeks

  • Exercise volume

    4 weeks

  • Peak force output

    4 weeks

Study Arms (3)

Protein hydrolysate high dose

EXPERIMENTAL
Dietary Supplement: Protein hydrolysate high dose

Protein hydrolysate low dose

EXPERIMENTAL
Dietary Supplement: Protein hydrolysate low dose

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Protein hydrolysate high dose
Protein hydrolysate low dose
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals (based on their medical history provided during a general health questionnaire)
  • Participants are amateur or (semi-) professional athletes in resistance or interval sports (engage in \>6 hours of intense physical activity per week).
  • Age 18 - 35
  • Experience in resistance training

You may not qualify if:

  • Use of creatine supplements and/or anabolic steroids.
  • Allergy to test product/protein
  • Allergy to specific protein hydrolysate
  • BMI lower than 18 or higher than 30.
  • Lack of technique in correctly performing a barbell squat (judged by sports physiologist).
  • Recent muscle injury in legs or back less than one month before the start of the study.
  • Cardiovascular complications
  • Use of medication
  • Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study.
  • Abuse of products; alcohol (\> 20 alcoholic units per week) and drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Protein Hydrolysates

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 24, 2017

Study Start

June 6, 2016

Primary Completion

February 9, 2017

Study Completion

February 20, 2017

Last Updated

March 3, 2017

Record last verified: 2017-03