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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048541
Receipt No. R000055304
Scientific Title Effects of consumption of the test food on skin condition in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Date of disclosure of the study information 2022/08/01
Last modified on 2022/08/01

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Basic information
Public title Effects of consumption of the test food on skin condition in healthy Japanese subjects
Acronym Effects of consumption of the test food on skin condition in healthy Japanese subjects
Scientific Title Effects of consumption of the test food on skin condition in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym Effects of consumption of the test food on skin condition in healthy Japanese subjects
Region
Japan

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

Objectives
Narrative objectives1 To verify the effects of consumption of the test food on skin condition in healthy Japanese subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. The moisture of the skin at eight weeks after consumption (8w)
Key secondary outcomes 1. The moisture of the skin at four weeks after consumption (4w)

2. Transepidermal water loss, viscoelasticity of the skin (cheek), and an original questionnaire (visual analogue scale) at 4w and 8w

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: Eight weeks
Test food: Fruits oil capsule (high amount)
Administration: Take two capsules with water at any time during the day

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2 Duration: Eight weeks
Test food: Fruits oil capsule (low amount)
Administration: Take two capsules with water at any time during the day

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_3 Duration: Eight weeks
Test food: Placebo capsule
Administration: Take two capsules with water at any time during the day

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
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. Japanese

2. Women

3. Subjects aged 20 or more

4. Healthy subjects

5. Subjects whose moisture of the skin is relatively low
Key exclusion criteria 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who have been diagnosed with atopic dermatitis

5. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily

6. Subjects who are currently taking medications (including herbal medicines) and supplements

7. Subjects who are allergic to medicines and/or the test food related products

8. Subjects who use any products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, skin lotions such as face masks, milky lotions, and sunscreen for daily skincare

9. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device)

10. Subjects who have undergone cosmetic surgery

11. Subjects who are pregnant, lactation, or planning to become pregnant during this trial

12. Subjects who suffer from COVID-19

13. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

14. Subjects who are judged as ineligible to participate in this study by the physician
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Tatsuya
Middle name
Last name Izumi
Organization Hiroo Dermatology Clinic & Mentors inc.
Division name Director
Zip code 150-0012
Address 1&2F Hiroo Masugi Annex Bldg., 5-25-5, Hiroo, Shibuya-ku, Tokyo, Japan
TEL 03-5795-1112
Email dr_izumi@orthomedico.jp

Public contact
Name of contact person
1st name Naoko
Middle name
Last name Suzuki
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization Gifu Shellac Manufacturing Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic

Hiroo Dermatology Clinic & Mentors inc.

Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email IRB@takara-clinic.com

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 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2022 Year 07 Month 20 Day
Date of IRB
2022 Year 07 Month 20 Day
Anticipated trial start date
2022 Year 08 Month 01 Day
Last follow-up date
2022 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 08 Month 01 Day
Last modified on
2022 Year 08 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055304

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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