UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of astaxanthin treatment on oxidative stress in women
Title of the study (Brief title)	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	Jui-Tung Chen
Organization	JT Chen Clinic
Division name	Gynecology
Address	B1F, 2-13-5 Akasaka, Minato-Ku Tokyo 1070052
TEL	0358560015
Email	jt107smile@gmail.com

Public contact
Name of contact person	Jui-Tung Chen
Organization	JT Chen Clinic
Division name	Gynecology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://bit.ly/2sZ26Yq
Results
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