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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01241877
Other study ID # MEC 10-3-068
Secondary ID
Status Recruiting
Phase N/A
First received November 15, 2010
Last updated April 19, 2011
Start date November 2010

Study information

Verified date April 2011
Source Maastricht University Medical Center
Contact Peter Res, MSc
Phone +3143381383
Email peter.res@maastrichtuniversity.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Use of medication

- Smoking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
astaxanthin
astaxanthin
placebo
placebo

Locations

Country Name City State
Netherlands Maastricht University Maastricht LI

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary time trial performance time trial performance 4 weeks No
Secondary substrate use 4 weeks No
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