NCT03045588

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 29, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

January 29, 2017

Last Update Submit

October 23, 2018

Conditions

Outcome Measures

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.

    Change from Baseline and after 4 weeks of training

Secondary Outcomes (2)

  • Protein expression in skeletal muscle tissue

    Baseline and after 4 weeks of training

  • The absolute amount of carbohydrate and fat which is metabolised during morning exercise, measured in grams/minute

    Baseline and after 4 weeks of training

Study Arms (2)

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.

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.

Other: Combined exercise and diet intervention

Interventions

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.

High groupLow group

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • VO2-max\>55 ml/kg/min
  • No smokers
  • Training 6 hours per week (cycling)
  • Training experience for more than 3 years.

You may not qualify if:

  • Less than 2 g carbohydrate/kg/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2017

First Posted

February 7, 2017

Study Start

October 1, 2016

Primary Completion

December 20, 2016

Study Completion

October 10, 2018

Last Updated

October 24, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share