Athletic PerformanceNCT01241877
Astaxanthin Supplementation in Cyclists
A study testing astaxanthin in people with Athletic Performance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Background of the study: Astaxanthin has been shown to be a powerfull anti-oxidant. Health benefits have been shown in animals and humans. Exercise enhancing effects have been shown in animals via enhancement of fat oxidation. 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
- Athletic Performance
- What is being tested?
- astaxanthin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2010to Jun 2011
- 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
- Healthy
- Male
- Age between 18 and 30 years
- Endurance trained (≥3 sessions of endurance exercise per week)
- VO2 max ≥ 50 ml/kg/min
- Training history of more than one year of ≥3 sessions of endurance exercise per week
- BMI <25 kg/m2
Who cannot join
- Use of medication
- Smoking
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht, LI, 6229
Peter Res, MSc, +3143381383, peter.res@maastrichtuniversity.nl
About this study
Background of the study:
Astaxanthin has been shown to be a powerfull anti-oxidant. Health benefits have been shown in animals and humans. Exercise enhancing effects have been shown in animals via enhancement of fat oxidation. We want to examine the effects of 4 weeks of astaxanthin supplementation on fat oxidation and cycling performance in trained cyclists
Read more
Objective of the study:
To test the hypothesis that 4 weeks supplementation with astaxanthin will improve fat oxidation and improve exercise performance in trained cyclists
Study design:
Double blind, placebo controlled study.
Study population:
Well trained cyclists between 18-30 years old
Intervention (if applicable):
astaxanthin (20 mg/day) or placebo for 4 weeks
Primary study parameters/outcome of the study:
performance on a time trial after 90 min steady state exercise.
Secundary study parameters/outcome of the study (if applicable):
substrate use plasma glucose plasma lactate plasma free fatty acid plasma astaxanthin
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
The risks involved in participating in this experiment are minimal. Astaxanthin has been shown to be safe. Insertion of the catheters in a vein is comparable to a normal blood draw and the only risk is of a small local haematoma.
- Conditions
- Athletic Performance
- Being tested
- astaxanthin, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
astaxanthinDietary supplement
astaxanthin
placeboDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| astaxanthin | Experimental | Not described Receives: Dietary Supplement: astaxanthin |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
time trial performance
time trial performance
Measured: 4 weeks
Secondary outcomes (1)
substrate use
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Athletic PerformanceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241877
- Sponsor's protocol ID
- MEC 10-3-068
- Status last verified
- Apr 2011
- First submitted
- 15 Nov 2010
- Last updated
- 20 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Klinkenberg LJ, Res PT, Haenen GR, Bast A, van Loon LJ, van Dieijen-Visser MP, Meex SJ. Effect of antioxidant supplementation on exercise-induced cardiac troponin release in cyclists: a randomized trial. PLoS One. 2013 Nov 19;8(11):e79280. doi: 10.1371/journal.pone.0079280. eCollection 2013.
PubMed 24260184
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Astaxanthin Supplementation in Cyclists
- ClinicalTrials.gov ID
- NCT01241877
- Acronym / sponsor ID
- MEC 10-3-068
- Conditions
- Athletic Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (estimated)
- First posted
- 16 Nov 2010 (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.
Background of the study:
Astaxanthin has been shown to be a powerfull anti-oxidant. Health benefits have been shown in animals and humans. Exercise enhancing effects have been shown in animals via enhancement of fat oxidation. We want to examine the effects of 4 weeks of astaxanthin supplementation on fat oxidation and cycling performance in trained cyclists
Objective of the study:
To test the hypothesis that 4 weeks supplementation with astaxanthin will improve fat oxidation and improve exercise performance in trained cyclists
Study design:
Double blind, placebo controlled study.
Study population:
Well trained cyclists between 18-30 years old
Intervention (if applicable):
astaxanthin (20 mg/day) or placebo for 4 weeks
Primary study parameters/outcome of the study:
performance on a time trial after 90 min steady state exercise.
Secundary study parameters/outcome of the study (if applicable):
substrate use plasma glucose plasma lactate plasma free fatty acid plasma astaxanthin
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
The risks involved in participating in this experiment are minimal. Astaxanthin has been shown to be safe. Insertion of the catheters in a vein is comparable to a normal blood draw and the only risk is of a small local haematoma.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| astaxanthin | Experimental | Dietary Supplement: astaxanthin |
| placebo | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy
- Male
- Age between 18 and 30 years
- Endurance trained (≥3 sessions of endurance exercise per week)
- VO2 max ≥ 50 ml/kg/min
Key exclusion criteria (2 listed)
- Use of medication
- Smoking
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 |
|---|---|---|
| astaxanthinastaxanthin | Dietary supplement | astaxanthin |
| placeboplacebo | Dietary supplement | placebo |
Primary outcome
time trial performance
Time frame: 4 weeks
time trial performance
1 secondary outcome
substrate use
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2011.
- Derived from this study: PubMed 24260184Klinkenberg LJ, Res PT, Haenen GR, Bast A, van Loon LJ, van Dieijen-Visser MP, Meex SJ. Effect of antioxidant supplementation on exercise-induced cardiac troponin release in cyclists: a randomized trial. PLoS One. 2013 Nov 19;8(11):e79280. doi: 10.1371/journal.pone.0079280. eCollection 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing astaxanthin in people with Athletic Performance, 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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Apr 2011. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Res, MSc (+3143381383, peter.res@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time trial performance (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01241877, which also lists 1 linked publication.
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 20 Apr 2011.