NCT01167205

Brief Summary

The purpose of this study is to determine whether astaxanthin (ASX) supplementation will reduce obesity-induced oxidative stress and improve lipid profile in overweight and obese adults.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

July 22, 2010

Status Verified

July 1, 2010

Enrollment Period

4 months

First QC Date

July 8, 2010

Last Update Submit

July 20, 2010

Conditions

Keywords

Healthy adults with BMI over 25.0 kg/m2

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the plasma MDA (malonaldehyde) level

    MDA is a three chain aldehyde produced during the composition of a lipid hydroperoxide and is a well known indicator of lipid peroxidation. The purpose of this stduy is to determine whether ASX supplementation lowers oxidative stress using MDA,a biomarker.

    12 weeks

Interventions

astaxanthinDIETARY_SUPPLEMENT

astaxanthin 20mg for 12 weeks

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects with BMI over 25.0 kg/m2
  • Non-smoker

You may not qualify if:

  • Excessive alcohol consumption
  • Pregnant or lactating women
  • Dyslipidemia, hyperglycemia, or other chronic diseases.
  • Subjects who were taking vitamin supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Institute Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Yeo-kyu Youn, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2010

First Posted

July 22, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

July 22, 2010

Record last verified: 2010-07

Locations