NCT02668445

Brief Summary

This is a randomized, counterbalanced crossover design, in which 14 male subjects will complete two experimental trials. Each trial will be separated by a minimum of at least 12 days (range: 12-30 days). The study aims to investigate the effects of low glycogen availability on skeletal muscle molecular response after a concurrent exercise day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

October 3, 2018

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

January 26, 2016

Last Update Submit

October 2, 2018

Conditions

Healthy

Keywords

Concurrentmuscleglycogenmolecular

Outcome Measures

Primary Outcomes (1)

  • Proteins involved in hypertrophy

    10 hours

Study Arms (2)

Low carbohydrate

EXPERIMENTAL

Subjects will eat a low carbohydrate diet

Other: Standard meal containing low or high carbohydrate content

High carbohydrate

EXPERIMENTAL

Subjects will eat a high carbohydrate diet

Other: Standard meal containing low or high carbohydrate content

Interventions

Standard meal containing low or high carbohydrate contentOTHER
High carbohydrateLow carbohydrate

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male gender between 18 and 30 years of age
  • BMI between 18.5 - 25 kg/m2
  • Participating in regular exercise training (at least 1 exercise session, and a maximum of 3 exercise session per week)
  • Used to different types of exercise (endurance, resistance and/or concurrent)
  • Willing to give blood samples
  • Willing to give muscle biopsies
  • No use of antibiotics during the study or in the past month
  • No drug use
  • Suitable veins for blood withdrawal
  • Registered by a general-practitioner
  • Consumption of alcohol beverages is less than 21 per week
  • No blood donor during the study
  • No vegetarian and willing to eat meat during the experimental days
  • Able to be present and participate at both test days and pre testing moments
  • Not employed, or intern, or working on thesis at the department of Human Nutrition at Wageningen University
  • +3 more criteria

You may not qualify if:

  • Medical condition that can interfere with the study outcome (i.e. cardiovascular disease, pulmonary disease, gluten intolerance)
  • Systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg
  • Use of medications known to interfere with gene expression in the muscles (i.e. statins, fenofibrate)
  • Use of antithrombotic therapy (marcoumar, sintromitis).
  • Diagnosed diabetes mellitus type 1 or 2
  • (Chronic) injuries of the locomotor system that can interfere with the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Human Nutrition, Wageningen University

Wageningen, Gelderland, 6703 HA, Netherlands

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

January 29, 2016

Study Start

November 1, 2015

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

October 3, 2018

Record last verified: 2016-02

Locations

NL(1)