Cycling PerformanceNCT03045588
The Effects of a Train High, Sleep Low Strategy
A study testing Combined exercise and diet intervention in people with Cycling Performance and Muscular Adaptations, run by University of Aarhus.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cycling Performance, Muscular Adaptations, Substrate Utilization
- What is being tested?
- Combined exercise and diet intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 10 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years
- VO2-max>55 ml/kg/min
- No smokers
- Training 6 hours per week (cycling)
- Training experience for more than 3 years.
Who cannot join
- Less than 2 g carbohydrate/kg/day
About this study
Official title: 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.
- Being tested
- Combined exercise and diet intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined exercise and diet interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Low group | Experimental | 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. Receives: Other: Combined exercise and diet intervention |
| High group | Active comparator | 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. Receives: Other: Combined exercise and diet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time trial performance measured in Watts
30 min time trial after 90 minutes of intensive cycling. The average amount of Watts during the 30 minutes will be measured.
Measured: Change from Baseline and after 4 weeks of training
Secondary outcomes (2)
Protein expression in skeletal muscle tissue
Amount of mitochondrial proteins and enzymes will be measured with a Western Blotting technique
Measured: Baseline and after 4 weeks of training
The absolute amount of carbohydrate and fat which is metabolised during morning exercise, measured in grams/minute
Fat and carbohydrate oxidation during exercise measured and estimated with indirect calorimetry.
Measured: Baseline and after 4 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Oct 2016
- Primary completion20 Dec 2016
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cycling PerformanceStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Team Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045588
- Sponsor's protocol ID
- Sleep low
- Status last verified
- Oct 2018
- First submitted
- 29 Jan 2017
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Train High, Sleep Low Strategy on Performance, Substrate Utilization and Muscular Adaptations in Moderately Trained Cyclists
- ClinicalTrials.gov ID
- NCT03045588
- Acronym / sponsor ID
- Sleep low
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Team Denmark
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low group | Experimental | Other: Combined exercise and diet interventionThis 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. |
| High group | Active comparator | Other: Combined exercise and diet interventionThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-45 years
- VO2-max>55 ml/kg/min
- No smokers
- Training 6 hours per week (cycling)
- Training experience for more than 3 years.
Key exclusion criteria (1 listed)
- Less than 2 g carbohydrate/kg/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined exercise and diet interventionBoth 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. | Other | High group, Low group |
Primary outcome
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.
2 secondary outcomes
Protein expression in skeletal muscle tissue
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Combined exercise and diet intervention in people with Cycling Performance and Muscular Adaptations, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time trial performance measured in Watts (time frame: Change from Baseline and after 4 weeks of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.