NCT03147001

Brief Summary

A randomized interventions study using a crossover design. Ten well trained triathletes or bikeriders will be included for to undergo two trail separated by about 3 weeks. The night before the trail each subject will performe a high intense interval trainings session on an ergometer bike. during the night an infusion of aminoacid tracers will be initiated. The subject is woken at 6.30 a.m. Blood samples and a musclebiopsy will be collected prior to the morning bike ride at 8.00a.m. Immediately before the morning bike ride is started the subject will ingest a drink of 0,5g protein or a non-caloric placebo (random order). During the bike ride and the following 4,5 hours blood will be drawn with regular intervals. at time point 0, 60 and 180 min after the training session biopsies are collected.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2017

Completed
4 months until next milestone

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
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

May 8, 2017

Last Update Submit

May 8, 2017

Conditions

Keywords

Endurance exerciseDietary protein

Outcome Measures

Primary Outcomes (1)

  • Muscle protein fractional synthetic rate (FSR)

    FSR was measure over at time period of six hours

Secondary Outcomes (3)

  • Tracer kinetics dilution model

    six hours

  • Muscle signalling

    Determined in biopsies sampled before and immediatly after 90min exercise in addition to one and four hours after exercise.

  • Nitrogen excretion

    Urine is collected during two periods. Collection period one: 12 hours prior to morning exercise. Collection period 2: During and four hours following exercise. Blood samples is drawn repeatedly from before to four hours after exercise.

Study Arms (2)

Protein ingestion

EXPERIMENTAL

Subjects ingested protein drinks

Other: Protein ingestion

Placebo

PLACEBO COMPARATOR

Subjects ingested a non-caloric placebo drink

Other: Non-caloric placebo ingestion

Interventions

A protein drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised).

Protein ingestion

A placebo drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised).

Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy well-trained triathletes or cyclists
  • VO2max \> 55 ml O2/kg/min
  • Training and has been training more than 7 times a week the last 6 months.

You may not qualify if:

  • VO2max \< 55 ml O2/kg/min
  • Has chronic disease
  • has incjected with tracer on a previous occasion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Larsen MS, Holm L, Svart MV, Hjelholt AJ, Bengtsen MB, Dollerup OL, Dalgaard LB, Vendelbo MH, van Hall G, Moller N, Mikkelsen UR, Hansen M. Effects of protein intake prior to carbohydrate-restricted endurance exercise: a randomized crossover trial. J Int Soc Sports Nutr. 2020 Jan 28;17(1):7. doi: 10.1186/s12970-020-0338-z.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Masking was done by providing similar tasting drinks at both trails. One was placebo, one was protein a drink
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, PhD

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 10, 2017

Study Start

April 30, 2016

Primary Completion

January 10, 2017

Study Completion

January 10, 2017

Last Updated

May 10, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share