UMIN-CTR Clinical Trial

Public title

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

Acronym

A verification study on effects of antioxidant and skin improvement in healthy Japanese adults

Scientific Title

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

Scientific Title:Acronym

A verification study on effects of antioxidant and skin improvement in healthy Japanese adults

Region

Japan

Condition

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Kazuo YAMAMOTO

Organization

ORTHOMEDICO, Inc.

Division name

R&D Department

Zip code

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.

TEL

03-3818-0610

Email

kazu@orthomedico.jp

Name of contact person

1st name
Middle name
Last name	Naoko SUZUKI

Organization

ORTHOMEDICO, Inc.

Division name

R&D Department

Zip code

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO, Inc.

Institute

Department

Personal name

Organization

Yagumo Kousan Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Seishin-kai Medical Association Inc, Takara Medical Clinic.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic (Tokyo)

Date of disclosure of the study information

2016

Year

06

Month

15

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

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.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

06

Month

13

Day

Date of IRB

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

Other related information

Registered date

2016

Year

06

Month

15

Day

Last modified on

2017

Year

08

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026220