NCT03147833

Brief Summary

32 runners will be randomized into two groups. The duration of the intervention is one week including a strenuous endurance training program. Group 1 receive a protein beverage before each night sleep and Group 2 receive an isocaloric carbohydrate beverage. Performance test before and after the intervention and blood sampling before and during the intervention to check for markers for muscle damage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable healthy

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

First Submitted

Initial submission to the registry

May 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2017

Completed
Last Updated

June 11, 2018

Status Verified

June 1, 2018

Enrollment Period

2 months

First QC Date

May 8, 2017

Last Update Submit

June 7, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Performance

    5 km time trial

    8 days

Secondary Outcomes (1)

  • Muscle damage

    8 days

Study Arms (2)

Sport beverages Protein

EXPERIMENTAL

Intervention group ingesting PROTEIN

Dietary Supplement: Sport beverages Protein

Sports beverage Carbohydrate

ACTIVE COMPARATOR

Placebo group ingesting carbohydrate

Dietary Supplement: Sport beverages Carbohydrate

Interventions

Sport beverages ProteinDIETARY_SUPPLEMENT

Beverage ingested before each night sleep during the intervention

Sport beverages Protein
Sport beverages CarbohydrateDIETARY_SUPPLEMENT

Beverage ingested before each night sleep during the intervention

Sports beverage Carbohydrate

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University, Department for Public Health, Section for Sport Science

Aarhus, 8000, Denmark

Location

Study Officials

  • Mette Hansen, PhD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 10, 2017

Study Start

August 1, 2017

Primary Completion

October 9, 2017

Study Completion

October 9, 2017

Last Updated

June 11, 2018

Record last verified: 2018-06

Locations

DK(1)