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CompletedNCT03045588Updated Oct 24, 2018

The Effects of a Train High, Sleep Low Strategy

An interventional study of Combined exercise and diet intervention in Cycling Performance, Muscular Adaptations and Substrate Utilization, sponsored by University of Aarhus. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-24.

Sponsored by University of Aarhus · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Oct 2016, registered Jan 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Cycling Performance
  • Muscular Adaptations
  • Substrate Utilization
03

In context

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Less than 2 g carbohydrate/kg/day
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • 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.

    Other: Combined exercise and diet intervention

  • 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.

    Other: Combined exercise and diet intervention

Interventions

  • OtherCombined exercise and diet intervention

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from Baseline and after 4 weeks of training

Secondary outcomes

  1. Protein expression in skeletal muscle tissue

    Amount of mitochondrial proteins and enzymes will be measured with a Western Blotting technique

    Time frame: Baseline and after 4 weeks of training

  2. 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.

    Time frame: Baseline and after 4 weeks of training

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03045588
Lead sponsor
University of Aarhus
Collaborators
Team Denmark
Responsible party
Sponsor
First posted
Feb 7, 2017
Start date
Oct 1, 2016
Primary completion
Dec 20, 2016
Completion
Oct 10, 2018
Last update
Oct 24, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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