UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of improvement the skin condition by ingestion of test food
Acronym	Evaluation of improvement the skin condition by ingestion of test food
Scientific Title	Evaluation of improvement the skin condition by ingestion of test food
Scientific Title:Acronym	Evaluation of improvement the skin condition by ingestion of test food
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to determine the effect of the test food on skin lightness by having healthy adults between the ages of 20 and 65 consume it for 12 weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin lightness (L-value)
Key secondary outcomes	(Secondary outcomes) number of Spots, number of wrinkles (Safety evaluation) Vital signs, physical measurements, adverse event

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
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	12-week intake of the test food(high doses)
Interventions/Control_2	12-week intake of the test food(low doses)
Interventions/Control_3	12-week intake of the placebo
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Japanese males and females who are between 20 and 65 years old at the time of obtaining written consent. 2. Those who have received a full explanation of the purpose and content of the study, have the ability to consent, understand the study well, and have volunteered to participate in the study and have agreed to participate in the study in writing.
Key exclusion criteria	1. Subject is currently receiving medication or outpatient treatment for any serious disease. 2. Subject is currently undergoing exercise or diet therapy under the supervision of a physician. 3. Subject is currently undergoing esthetic salon, beauty treatment (laser treatment, etc.) or beauty treatment (Zeo Skin, etc.) under the supervision of a physician. 4. Subject may develop allergies to the test food. 5. Subject have a current or history of drug dependence or alcohol dependence. 6. Subject is hospitalized for mental disorders (depression, etc.) or sleep disorders, or have a history of mental disorders in the past. 7. Subject is have irregular rhythm of life due to night work or shift work. 8. Subject is with extremely irregular eating, sleeping, or other habits. 9. Subject have an extremely unbalanced diet 10.Subject have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, liver diseases (hepatitis), kidney diseases, heart diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases.
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Yamatsu
Organization	Pharma Foods International Co., Ltd.
Division name	Research and Development
Zip code	615-8245
Address	1-49, Goryo-ohara, nishikyo-ku, Kyoto city, Kyoto, Japan
TEL	075-748-9829
Email	a-yamatsu@pharmafoods.co.jp

Public contact
Name of contact person	1st name Yukihiro Middle name Last name Yamaji
Organization	M&I Science CORP.
Division name	Public Relations Department
Zip code	531-0071
Address	Nakatsugurando Bld.10F, 1-17-26, Nakatsu, Osaka Shi Kita Ku, Osaka Fu, 531-0071, Japan
TEL	06-7878-6780
Homepage URL
Email	y.yamaji@mis21.co.jp

Sponsor
Institute	Pharma Foods International Co., Ltd.
Institute
Department

Funding Source
Organization	Mitsubishi Corporation Life Sciences Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	NISHI-UMEDA Clinic for Asian Medical Collaboration Clinical Research Institutional Review Board
Address	West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
Tel	06-4797-5660
Email	jimukyoku@amc-clinc.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	MPF01-002
Org. issuing International ID_1	Pharma Foods International Co., Ltd. M&I Science
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 10 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	Completed
Date of protocol fixation	2021 Year 10 Month 25 Day
Date of IRB	2021 Year 10 Month 28 Day
Anticipated trial start date	2021 Year 11 Month 11 Day
Last follow-up date	2022 Year 03 Month 15 Day
Date of closure to data entry	2022 Year 04 Month 15 Day
Date trial data considered complete	2022 Year 04 Month 19 Day
Date analysis concluded	2022 Year 08 Month 05 Day

Other

Other related information

(Exclusion criteria continued) 11. Subject use health foods, supplements, and medicines (ingredients: glutathione, cysteine, yeast extract, vitamins, placenta, hyaluronic acid, collagen, etc.) that have a beautiful skin effect or may affect the improvement of skin quality. 12. Subject live in an environment that is prone to sunburn on a daily basis (e.g., those who work outdoors a lot or have a habit of exercising outdoors) 13. Subject have participated in other clinical trials (research) within 3 months retrospectively from the date of obtaining consent, or those who have plans to participate in other clinical trials (research) during the study period 14. Subject have collected more than 200 mL of blood or donated more than 400 mL of blood within 1 month or 3 months prior to the date of obtaining consent. 15. Subject is currently pregnant or breastfeeding. or is likely to become so during the study period. 16. Subject who have difficulty in complying with the recording of various questionnaires. 17. Subject judged to be unsuitable as subjects based on clinical laboratory values and measurements at the time of SCR. 18. others, subject who are judged unsuitable as subjects by the principal

Management information
Registered date	2021 Year 11 Month 10 Day
Last modified on	2022 Year 11 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052535