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A Study of the Effect of Test Supplement on Oxidative Stress in healthy subjects. A Randomized, Double-blind, Placebo controlled Study.

Not Applicable
Conditions
Healthy adult
Registration Number
JPRN-UMIN000028519
Lead Sponsor
KSO Corporation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
112
Inclusion Criteria

Not provided

Exclusion Criteria

(1)Subjects who have serious diseases requiring an urgent treatment, or who have chronic illness and use medicines constantly. (2)Subjects who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement (except for appendectomy.) (3)Subjects who use supplements and health foods (including food for specified health use and food with nutrient function claims) constantly that could affect antioxidant status (4)Subjects who ingest many polyphenol-containing beverages such as green tea and coffee (more than 3 cups per day). (5)Subjects who declared that they have allergies to the ingredients of the test supplement. (6)Subjects who have a history of developing seasonal allergy during this study period (July - December). (7)Subjects who are pregnant or willing to be pregnant or breast-feeding during this study. (8)Subjects who have a current or history of drug dependence and/or alcoholism. (9)Subjects who were judged as unsuitable for this study by the principal investigator from the clinical examination performed in the screening test. (10)Subjects who are participating in other clinical trial that intake/apply any of food, drug, and cosmetics, or willing to participate. (11)Subjects who are judged unsuitable for this study by the principal investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Evaluate the effects on Measurement items related to oxidative stress
Secondary Outcome Measures
NameTimeMethod
Evaluate the effects on mental and physical conditions by questionnaires and related-measurement items
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