HealthyGlyconcurrentNCT02668445
Molecular Response After Concurrent Exercise With Low Glycogen
A study testing Standard meal containing low or high carbohydrate content in people with Healthy, run by Wageningen University at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Standard meal containing low or high carbohydrate content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Division of Human Nutrition, Wageningen University
Wageningen, Gelderland, 6703 HA
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Standard meal containing low or high carbohydrate content
- Keywords
- Concurrent, muscle, glycogen, molecular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard meal containing low or high carbohydrate contentOther
| Study group | Role | What they receive |
|---|---|---|
| Low carbohydrate | Experimental | Subjects will eat a low carbohydrate diet Receives: Other: Standard meal containing low or high carbohydrate content |
| High carbohydrate | Experimental | Subjects will eat a high carbohydrate diet Receives: Other: Standard meal containing low or high carbohydrate content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteins involved in hypertrophy
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668445
- Sponsor's protocol ID
- NL54408.081.15
- Acronym
- Glyconcurrent
- Status last verified
- Feb 2016
- First submitted
- 26 Jan 2016
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Glycogen Availability on the Skeletal Muscle Molecular Response After Concurrent Exercise
- ClinicalTrials.gov ID
- NCT02668445
- Acronym / sponsor ID
- Glyconcurrent / NL54408.081.15
- Conditions
- Healthy
- Keywords
- Concurrent, muscle, glycogen, molecular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate | Experimental | Other: Standard meal containing low or high carbohydrate contentSubjects will eat a low carbohydrate diet |
| High carbohydrate | Experimental | Other: Standard meal containing low or high carbohydrate contentSubjects will eat a high carbohydrate diet |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard meal containing low or high carbohydrate content | Other | High carbohydrate, Low carbohydrate |
Primary outcome
Proteins involved in hypertrophy
Time frame: 10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard meal containing low or high carbohydrate content in people with Healthy, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteins involved in hypertrophy (time frame: 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.