- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02668445
Molecular Response After Concurrent Exercise With Low Glycogen (Glyconcurrent)
October 2, 2018 updated by: Wageningen University
The Effects of Glycogen Availability on the Skeletal Muscle Molecular Response After Concurrent Exercise
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Two experimental exercise trials; a low carbohydrate (= LOW) and a high carbohydrate (= HIGH) trial.
During both experimental days subjects will complete an continues submaximal cycling bout in the morning followed by a resistance exercise session in the early afternoon.
During the LOW trial subjects will receive a low carbohydrate mixed meal, during the HIGH trial subjects will be provided with a high carbohydrate meal.
In addition, on both experimental days subjects will receive adequate protein beverages.
Lastly, protein will be provided post resistance exercise.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gelderland
-
Wageningen, Gelderland, Netherlands, 6703 HA
- Division of Human Nutrition, Wageningen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
- Not participating in another scientific study (except EetMeetWeet)
- Able to participate during the experimental days en pre tests
- Able to speak Dutch
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low carbohydrate
Subjects will eat a low carbohydrate diet
|
|
|
Experimental: High carbohydrate
Subjects will eat a high carbohydrate diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proteins involved in hypertrophy
Time Frame: 10 hours
|
10 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
January 26, 2016
First Submitted That Met QC Criteria
January 28, 2016
First Posted (Estimate)
January 29, 2016
Study Record Updates
Last Update Posted (Actual)
October 3, 2018
Last Update Submitted That Met QC Criteria
October 2, 2018
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NL54408.081.15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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