- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03147001
Protein Ingestion Before Training Low
May 8, 2017 updated by: Mette Hansen, University of Aarhus
Nutritional Strategies for Optimizing Adaptations and Recovery Following Training 'Low'.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- VO2max < 55 ml O2/kg/min
- Has chronic disease
- has incjected with tracer on a previous occasion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Protein ingestion
Subjects ingested protein drinks
|
A protein drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised).
|
PLACEBO_COMPARATOR: Placebo
Subjects ingested a non-caloric placebo drink
|
A placebo drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Muscle protein fractional synthetic rate (FSR)
Time Frame: FSR was measure over at time period of six hours
|
FSR was measure over at time period of six hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tracer kinetics dilution model
Time Frame: six hours
|
A-V tracer dilution model was applied across the forearm.
|
six hours
|
Muscle signalling
Time Frame: Determined in biopsies sampled before and immediatly after 90min exercise in addition to one and four hours after exercise.
|
Muscle signalling will be determined using western blotting in each muscle biopsy
|
Determined in biopsies sampled before and immediatly after 90min exercise in addition to one and four hours after exercise.
|
Nitrogen excretion
Time Frame: 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.
|
nitrogen excretion is determined by Plasma and urinary carbide analysis as well as plasma NH4+.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 30, 2016
Primary Completion (ACTUAL)
January 10, 2017
Study Completion (ACTUAL)
January 10, 2017
Study Registration Dates
First Submitted
May 8, 2017
First Submitted That Met QC Criteria
May 8, 2017
First Posted (ACTUAL)
May 10, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 10, 2017
Last Update Submitted That Met QC Criteria
May 8, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 50968
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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