UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A verification study on effects of antioxidant and skin improvement in healthy Japanese adults: a open-label trial
Title of the study (Brief title)	A verification study on effects of antioxidant and skin improvement in healthy Japanese adults
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify antioxidative and skin improving effects due to the ingestion of the test food
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	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
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 8 weeks Test material: Paste of Fermented Plant Extract AO Dose: 1 pack a day Administration: Take the test food before breakfast
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1. Healthy Japanese adult females 2. Healthy adult females who feel fatigue
Key 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
Target sample size	26

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	Naoko SUZUKI
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO, Inc.
Institute
Department

Funding Source
Organization	Yagumo Kousan Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seishin-kai Medical Association Inc, Takara Medical Clinic.
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	広尾皮フ科クリニック (東京都) Hiroo Dermatology Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 13 Day
Anticipated trial start date	2016 Year 06 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	[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.
Other related information

Management information
Registered date	2016 Year 06 Month 15 Day
Last modified on	2017 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026220