UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011834
Receipt number R000013834
Scientific Title The effect of astaxanthin treatment on oxidative stress in women
Date of disclosure of the study information 2013/10/01
Last modified on 2017/07/17 17:04:18

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Basic information

Public title

The effect of astaxanthin treatment on oxidative stress in women

Acronym

Effect of astaxanthin treatment on oxidative stress

Scientific Title

The effect of astaxanthin treatment on oxidative stress in women

Scientific Title:Acronym

Effect of astaxanthin treatment on oxidative stress

Region

Japan


Condition

Condition

Women in perimenopause and within 5 years after menopause. Inclusion criteria are those with an increased oxidative stress marker: more than 300 Carr Units measured by the Diacron-reactive oxygen metabolites test and low antioxidant state, less than 2000 micro Units, by the biological anti-oxidant potential test.

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Perimenpausal and early postmenopausal women can have an increase of oxidative stress and decrease of antioxidant potential due to decline in estrogen levels, leading to an increased cardiovascular disease risk. Astaxanthin is known to have an antioxidant capacity and safely used as a supplement. The effect of antioxidant potential of astaxanthin supplementation is not fully reported clinically in the female population. The aim of this study is to observe the effect of astaxanthin supplementation on oxidative stress conditions in perimenpausal and early (within 5 years) postmenopausal women.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Before, and 4, 8, 12 weeks after the supplement, all participants are interviewed for their medical histories, subjective symptoms, anti-aging common questionnaire, simplified menopausal index, questionnaire for poor circulation, and the status of the supplement. Measurements of body height and weight, blood pressure, and blood oxidative stress measured by the Diacron-reactive oxygen metabolites test and antioxidant state by the biological anti-oxidant potential test.

Key secondary outcomes

General blood count, coagulation and fibrinolysis, liver and kidney function, lipids and lipoproteins, inflammatory and oxidative markers, 17-beta E2, FSH, and general urinalysis were measured before and 12 months after the treatment.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Participants are taken one capsule (an astaxanthin capsule including 12mg of astaxanthin) once a day for 12 weeks.

Interventions/Control_2

A placebo capsule is taken one capsule once a day for 12 weeks.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Women in perimenopause or within 5 years after menopause. Inclusion criteria are those with an increased oxidative stress marker: more than 300 Carr Units measured by the Diacron-reactive oxygen metabolites test and low antioxidant state, less than 2000 micro Units, by the biological anti-oxidant potential test.

Key exclusion criteria

A: women with under 300 Carr Units measured by the Diacron-reactive oxygen metabolites test and a normal antioxidant state, over 2000 micro Units, by the biological anti-oxidant potential test. B: smoker. C: women receiving hormone replacement therapy. D: women taking antioxidant supplements or vitamins. E: women receiving treatment for chronic heart failure, renal failure, hepatitis, or malignancies. F: The doctor approved inappropriate incorporating for this study.

Target sample size

140


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jui-Tung Chen

Organization

JT Chen Clinic

Division name

Gynecology

Zip code


Address

B1F, 2-13-5 Akasaka, Minato-Ku Tokyo 1070052

TEL

0358560015

Email

jt107smile@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Jui-Tung Chen

Organization

JT Chen Clinic

Division name

Gynecology

Zip code


Address

B1F, 2-13-5 Akasaka, Minato-Ku Tokyo 1070052

TEL

0358560015

Homepage URL

http://www.chin-cl.com

Email

jtsmile107@yahoo.co.jp


Sponsor or person

Institute

JT Chen Clinic

Institute

Department

Personal name



Funding Source

Organization

JT Chen Clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

陳瑞東クリニック(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://bit.ly/2sZ26Yq

Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 10 Month 09 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 24 Day

Last follow-up date

2016 Year 09 Month 30 Day

Date of closure to data entry

2016 Year 10 Month 31 Day

Date trial data considered complete

2016 Year 12 Month 31 Day

Date analysis concluded

2017 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 09 Month 23 Day

Last modified on

2017 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013834


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name