Exercise RecoveryNCT00975390
Muscle Glycogen Synthesis When Caffeine and Protein is Co-Ingested With Carbohydrates
A study testing Carbohydrate, Carbohydrate and protein ingestion and Carbohydrate and caffeine ingestion in people with Exercise Recovery, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The aim of the present study is to investigate the effect of added protein+leucine or caffeine to 1.2 g/kg/h CHO on the rate of post-exercise muscle glycogen re-synthesis in healthy, recreational athletes. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Recovery
- What is being tested?
- Carbohydrate, Carbohydrate and protein ingestion and Carbohydrate and caffeine ingestion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2009to Sep 2009
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male cyclists
- healthy
- BMI < 25
Who cannot join
- female
- use of medication
- non cycling
- BMI > 25
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Caffeine or Protein Co-ingestion With Carbohydrate on Post-exercise Muscle Glycogen Synthesis Rate.
The aim of the present study is to investigate the effect of added protein+leucine or caffeine to 1.2 g/kg/h CHO on the rate of post-exercise muscle glycogen re-synthesis in healthy, recreational athletes.
The investigators hypothesize that both interventions (the addition of caffeine or protein+leucine) will lead to higher glycogen re-synthesis compared to the ingestion of CHO only, and that the co-ingestion of protein and leucine will result in the highest muscle glycogen synthesis rates.
- Conditions
- Exercise Recovery
- Being tested
- Carbohydrate, Carbohydrate and protein ingestion, Carbohydrate and caffeine ingestion
- Keywords
- Glycogen, Carbohydrate, Protein, Caffeine, Post exercise muscle glycogen synthesis, Sports nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbohydrateDietary supplement
1.2 g/kg/h
Carbohydrate and protein ingestionDietary supplement
1.2 g/kg/h carbohydrate plus 0.4 g/kg/h protein
Carbohydrate and caffeine ingestionDietary supplement
1.2 g/kg/h carbohydrate and 1.67 g/kg/h caffeine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Carbohydrate ingestion Receives: Dietary Supplement: Carbohydrate |
| 2 | Experimental | Carbohydrate and protein ingestion Receives: Dietary Supplement: Carbohydrate and protein ingestion |
| 3 | Experimental | Carbohydrate and caffeine ingestion Receives: Dietary Supplement: Carbohydrate and caffeine ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle glycogen synthesis rates
Measured: 6 hours
Secondary outcomes (1)
Glycogen synthase activity, plasma glucose, insulin, free fatty acids and epinephrine responses
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise RecoveryStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milou Beelen, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975390
- Sponsor's protocol ID
- 08-3-066
- Status last verified
- Apr 2015
- First submitted
- 10 Sep 2009
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Caffeine or Protein Co-ingestion With Carbohydrate on Post-exercise Muscle Glycogen Synthesis Rate.
- ClinicalTrials.gov ID
- NCT00975390
- Acronym / sponsor ID
- 08-3-066
- Conditions
- Exercise Recovery
- Keywords
- Glycogen, Carbohydrate, Protein, Caffeine, Post exercise muscle glycogen synthesis, Sports nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Sep 2009 (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.
The aim of the present study is to investigate the effect of added protein+leucine or caffeine to 1.2 g/kg/h CHO on the rate of post-exercise muscle glycogen re-synthesis in healthy, recreational athletes.
The investigators hypothesize that both interventions (the addition of caffeine or protein+leucine) will lead to higher glycogen re-synthesis compared to the ingestion of CHO only, and that the co-ingestion of protein and leucine will result in the highest muscle glycogen synthesis rates.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: CarbohydrateCarbohydrate ingestion |
| 2 | Experimental | Dietary Supplement: Carbohydrate and protein ingestionCarbohydrate and protein ingestion |
| 3 | Experimental | Dietary Supplement: Carbohydrate and caffeine ingestionCarbohydrate and caffeine ingestion |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male cyclists
- healthy
- BMI < 25
Key exclusion criteria (4 listed)
- female
- use of medication
- non cycling
- BMI > 25
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 |
|---|---|---|
| Carbohydrate1.2 g/kg/h | Dietary supplement | 1 |
| Carbohydrate and protein ingestion1.2 g/kg/h carbohydrate plus 0.4 g/kg/h protein | Dietary supplement | 2 |
| Carbohydrate and caffeine ingestion1.2 g/kg/h carbohydrate and 1.67 g/kg/h caffeine | Dietary supplement | 3 |
Primary outcome
Muscle glycogen synthesis rates
Time frame: 6 hours
1 secondary outcome
Glycogen synthase activity, plasma glucose, insulin, free fatty acids and epinephrine responses
Time frame: 6 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 14 Apr 2015.
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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 Carbohydrate, Carbohydrate and protein ingestion and Carbohydrate and caffeine ingestion in people with Exercise Recovery, run by Maastricht University Medical Center 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 3 inclusion and 4 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 14 Apr 2015. 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?
Muscle glycogen synthesis rates (time frame: 6 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 14 Apr 2015.