UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046030 |
|---|---|
| Receipt number | R000052535 |
| Scientific Title | Evaluation of improvement the skin condition by ingestion of test food |
| Date of disclosure of the study information | 2021/11/10 |
| Last modified on | 2022/11/14 13:13:43 |
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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
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
y.yamaji@mis21.co.jp
Sponsor or person
Institute
Pharma Foods International Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052535
