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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011834
Receipt No. 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

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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
Obsterics 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
Institute JT Chen Clinic
Institute
Department

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
URL(English) https://upload.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


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