NCT01241877

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

April 20, 2011

Status Verified

April 1, 2011

Enrollment Period

7 months

First QC Date

November 15, 2010

Last Update Submit

April 19, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • time trial performance

    time trial performance

    4 weeks

Secondary Outcomes (1)

  • substrate use

    4 weeks

Study Arms (2)

astaxanthin

EXPERIMENTAL
Dietary Supplement: astaxanthin

placebo

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

astaxanthinDIETARY_SUPPLEMENT

astaxanthin

astaxanthin
placeboDIETARY_SUPPLEMENT

placebo

placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Use of medication
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, LI, 6229, Netherlands

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Interventions

astaxanthine

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 16, 2010

Study Start

November 1, 2010

Primary Completion

June 1, 2011

Last Updated

April 20, 2011

Record last verified: 2011-04

Locations