The effect of astaxanthin treatment on oxidative stress in women

UMIN ID: UMIN000011834

Registered date:01/10/2013

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: 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.
• Date of first enrollment: 2013/09/24
• Target sample size: 140
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: 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.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female
• Exclude 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.

Related Information

• Primary Sponsor: JT Chen Clinic
• Source(s) of Monetary Support: JT Chen Clinic