- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03045588
The Effects of a Train High, Sleep Low Strategy
October 23, 2018 updated by: University of Aarhus
The Effects of a Train High, Sleep Low Strategy on Performance, Substrate Utilization and Muscular Adaptations in Moderately Trained Cyclists
The investigators will examine the long-term effects of a combined training and diet intervention that, acutely, increases fat oxidation during exercise.
This is done with a 4 week intervention study with moderately trained cyclists.
Performance is tested pre and post intervention and muscle biopsies are obtained.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 18-45 years
- VO2-max>55 ml/kg/min
- No smokers
- Training 6 hours per week (cycling)
- Training experience for more than 3 years.
Exclusion Criteria:
- Less than 2 g carbohydrate/kg/day
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low group
This subjects in this group conducts all their morning exercise sessions with high fat oxidation (in a fasted condition).
Thus, the subjects in this group after high intensity exercise in the evening do not get any carbohydrates to eat after training until the exercise session the following morning has been conducted.
|
Both groups exercise 6 times per week in 4 weeks conducted as 3 evening and 3 morning sessions per week.
Both groups receive dietary products to be consumed immediately before and after each evening and morning session, respectively.
One group conduct morning sessions in a fasted state, the other conduct the morning sessions in a fed state.
Performance pre and post is measured, and muscle biopsies are obtained.
|
Active Comparator: High group
This subjects in this group conducts all their morning exercise sessions with low fat oxidation (in a fed condition).
Thus, the subjects in this group after high intensity exercise in the evening do get carbohydrates to eat after training until the exercise session the following morning has been conducted.
|
Both groups exercise 6 times per week in 4 weeks conducted as 3 evening and 3 morning sessions per week.
Both groups receive dietary products to be consumed immediately before and after each evening and morning session, respectively.
One group conduct morning sessions in a fasted state, the other conduct the morning sessions in a fed state.
Performance pre and post is measured, and muscle biopsies are obtained.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time trial performance measured in Watts
Time Frame: Change from Baseline and after 4 weeks of training
|
30 min time trial after 90 minutes of intensive cycling.
The average amount of Watts during the 30 minutes will be measured.
|
Change from Baseline and after 4 weeks of training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protein expression in skeletal muscle tissue
Time Frame: Baseline and after 4 weeks of training
|
Amount of mitochondrial proteins and enzymes will be measured with a Western Blotting technique
|
Baseline and after 4 weeks of training
|
The absolute amount of carbohydrate and fat which is metabolised during morning exercise, measured in grams/minute
Time Frame: Baseline and after 4 weeks of training
|
Fat and carbohydrate oxidation during exercise measured and estimated with indirect calorimetry.
|
Baseline and after 4 weeks of training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
October 1, 2016
Primary Completion (Actual)
December 20, 2016
Study Completion (Actual)
October 10, 2018
Study Registration Dates
First Submitted
January 29, 2017
First Submitted That Met QC Criteria
February 6, 2017
First Posted (Estimate)
February 7, 2017
Study Record Updates
Last Update Posted (Actual)
October 24, 2018
Last Update Submitted That Met QC Criteria
October 23, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- Sleep low
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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