HealthyNCT03147833
Protein Before Night Sleep to Improve Recovery and Performance in Runners
A study testing Sport beverages Protein and Sport beverages Carbohydrate in people with Healthy, run by University of Aarhus at 1 site in Denmark.
Trial summary
32 runners will be randomized into two groups. The duration of the intervention is one week including a strenuous endurance training program. Group 1 receive a protein beverage before each night sleep and Group 2 receive an isocaloric carbohydrate beverage. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sport beverages Protein and Sport beverages Carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2017to 9 Oct 2017
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department for Public Health, Section for Sport Science
Aarhus, 8000
About this study
Official title: Ingestion of Protein Before Each Night Sleep to Improve Recovery and Performance in Runners
32 runners will be randomized into two groups. The duration of the intervention is one week including a strenuous endurance training program. Group 1 receive a protein beverage before each night sleep and Group 2 receive an isocaloric carbohydrate beverage. Performance test before and after the intervention and blood sampling before and during the intervention to check for markers for muscle damage.
- Conditions
- Healthy
- Being tested
- Sport beverages Protein, Sport beverages Carbohydrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sport beverages ProteinDietary supplement
Beverage ingested before each night sleep during the intervention
Sport beverages CarbohydrateDietary supplement
Beverage ingested before each night sleep during the intervention
| Study group | Role | What they receive |
|---|---|---|
| Sport beverages Protein | Experimental | Intervention group ingesting PROTEIN Receives: Dietary Supplement: Sport beverages Protein |
| Sports beverage Carbohydrate | Active comparator | Placebo group ingesting carbohydrate Receives: Dietary Supplement: Sport beverages Carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
5 km time trial
Measured: 8 days
Secondary outcomes (1)
Muscle damage
creatine kinase
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Aug 2017
- Primary completion9 Oct 2017
- Study completion9 Oct 2017
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.
- More trials run by University of AarhusThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Hansen, University of Aarhus
- Investigators
- Mette Hansen, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147833
- Sponsor's protocol ID
- 1107229216
- Status last verified
- Jun 2018
- First submitted
- 8 May 2017
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ingestion of Protein Before Each Night Sleep to Improve Recovery and Performance in Runners
- ClinicalTrials.gov ID
- NCT03147833
- Acronym / sponsor ID
- 1107229216
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 10 May 2017 (actual)
- 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.
32 runners will be randomized into two groups. The duration of the intervention is one week including a strenuous endurance training program. Group 1 receive a protein beverage before each night sleep and Group 2 receive an isocaloric carbohydrate beverage. Performance test before and after the intervention and blood sampling before and during the intervention to check for markers for muscle damage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sport beverages Protein | Experimental | Dietary Supplement: Sport beverages ProteinIntervention group ingesting PROTEIN |
| Sports beverage Carbohydrate | Active comparator | Dietary Supplement: Sport beverages CarbohydratePlacebo group ingesting carbohydrate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Sport beverages ProteinBeverage ingested before each night sleep during the intervention | Dietary supplement | Sport beverages Protein |
| Sport beverages CarbohydrateBeverage ingested before each night sleep during the intervention | Dietary supplement | Sports beverage Carbohydrate |
Primary outcome
Performance
Time frame: 8 days
5 km time trial
1 secondary outcome
Muscle damage
Time frame: 8 days
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 11 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
Mette Hansen, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sport beverages Protein and Sport beverages Carbohydrate in people with Healthy, run by University of Aarhus at 1 site in Denmark.
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 0 inclusion and 1 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 11 Jun 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 Denmark. 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?
Performance (time frame: 8 days). 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 11 Jun 2018.