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A verification study on effects of antioxidant and skin improvement in healthy Japanese adults: a open-label trial

Not Applicable
Conditions
Healthy adults
Registration Number
JPRN-UMIN000022761
Lead Sponsor
ORTHOMEDICO, Inc.
Brief Summary

[1] Iio S, Hondoh K, Suzuki N, Yamashita S, Izumi T. A verification study on effects of Paste of Fermented Plant Extract AO on antioxidant and skin improvement in healthy Japanese adults: a open-label trial. The 15th Annual Meeting of the Japanese Society of Preventive Medicine. 2017, p.55 [2] Hondoh K, Yamashita S, Suzuki N, Izumi T. Effects of Paste of Fermented Plant Extract AO on Antioxidant Capacity and Skin Condition in Healthy Japanese Women-An Open Trial-. Jpn Pharmacol Ther. 2017; 45(7): 1153-1164.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
26
Inclusion Criteria

Not provided

Exclusion Criteria

1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, Irritable Bowel Syndrome (IBS) or other chronic diseases 3. Currently taking medicines (include herbal medicines), supplements, Food for Specified Health Uses, and/or Foods with Functional Claims 4. Allergic to soybean, apple, banana, peach, kiwi fruit, yam, sesame, medicines or foods related to the test food of this trial 5. Pregnant, lactating, or planning to get pregnant during the trial period 6. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 7. Judged unsuitable for participating in this trial by physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Urine 8-hydroxydeoxyguanosine 2. Blood potential anti oxidant 3. Simplified Oxidative Stress Profile 4. Hexanoyl lysine (HEL) 5. Propanoyl lysine (PRL) *Measuring points: at 0 week and 8 weeks after ingestion
Secondary Outcome Measures
NameTimeMethod
1. Questionnaire (Likert scale) 2. Skin oiliness 3. Skin moisture 4. Skin elasticity 5. Magnified image skin diagnosis *Measuring points: at 0 week and 8 weeks after ingestion
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