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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03045588
Other study ID # Sleep low
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2016
Est. completion date October 10, 2018

Study information

Verified date October 2018
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 10, 2018
Est. primary completion date December 20, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

Other:
Combined 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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Team Denmark

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from Baseline and after 4 weeks of training
Secondary Protein expression in skeletal muscle tissue Amount of mitochondrial proteins and enzymes will be measured with a Western Blotting technique Baseline and after 4 weeks of training
Secondary 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. Baseline and after 4 weeks of training
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