Positive Effects of Haematococcus Astaxanthin on Oxidativ... | NCT01167205

Studies
Positive Effects of Haematococcus Astaxanthin on Oxidative Stress and Lipid Profile in Overweight and Obese Adults

NCT01167205

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jul 22, 2010Estimated

Enrollment

Phase

Not Applicable

Conditions

Healthy
Overweight
Obesity

Interventions

astaxanthin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Dec 2010

Completion Date

Mar 2011

First Submitted Date

Jul 8, 2010

First Submission Date that Met QC Criteria

Jul 20, 2010

First Posted Date

Jul 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2010

Last Update Posted Date

Jul 22, 2010Estimated

Name	Class
Ministry of Health & Welfare, Korea	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
astaxanthin	Dietary Supplement	astaxanthin 20mg for 12 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with BMI over 25.0 kg/m2
Non-smoker

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yeo-kyu Youn, Doctor	Contact	+82 2 2072 3447		ykyoun@snu.ac.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Institute Seoul National University Hospital		Seoul	Seoul	110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C005948	astaxanthine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided