Unique ID issued by UMIN | UMIN000046844 |
---|---|
Receipt number | R000053369 |
Scientific Title | Study for the Effects of a Test Food on Skin Function. |
Date of disclosure of the study information | 2023/04/17 |
Last modified on | 2022/11/04 15:21:09 |
Study for the Effects of a Test Food on Skin Function.
Study for the Effects of a Test Food on Skin Function.
Study for the Effects of a Test Food on Skin Function.
Study for the Effects of a Test Food on Skin Function.
Japan |
No(Healthy adults)
Not applicable | Adult |
Others
NO
This study examines effects of a test food on skin function.
Safety,Efficacy
Indexes for skin function.
[1]Transepidermal water loss (Week 0, Week 8).
[2]Skin moisture content (Week 0, Week 8).
*Secondary indexes
[1] Skin viscoelasticity (Week 0, Week 8).
[2] Observation for skin condition by dermatologists (Week 0, Week 8).
[3] Skin Age measurement (Week 0, Week 8).
[4] Plasma pentosidine (Week 0, Week 8).
[5] Visual Analogue Scale (Week 0, Week 4, Week 8).
*Safety
[1] Blood pressure, pulsation (Week 0, Week 8).
[2] Weight, body fat percentage, BMI (Week 0, Week 8).
[3] Blood test (Week 0, Week 8).
[4] Blood biochemical test (Week 0, Week 8).
[5] Urine analysis (Week 0, Week 8).
[6] Doctor's questions (Week 0, Week 8).
[7] Adverse events: number of cases and expression rate of adverse events (Week 8).
[8] Subject's diary (From the first day of ingestion of a test material to the last day of the test).
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Treatment
Food |
Oral intake of the test product A (10 capsules in a day; 8 weeks).
Oral intake of the test product B (10 capsules in a day; 8 weeks).
Oral intake of the placebo product (10 capsules in a day; 8 weeks).
40 | years-old | <= |
65 | years-old | > |
Female
[1] Healthy Japanese females aged 40-64 years.
[2] Individuals who are healthy and have no chronic physical disease including skin disease.
[3] Individuals who are aware of skin dryness.
[4] Individuals whose written informed consent has been obtained after explanation of this study.
[5] Individuals who can have an examination on a designated check day
[6] Individuals judged appropriate for the study by the principal.
[1] Individuals using medical products.
[2] Individuals with strange skin conditions at measurement points.
[3] Individuals with strange skin conditions at measurement points.
[4] Individuals who used a drug to treat a disease in the past 1 month.
[5] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[6] Individuals who contract or have a history of serious gastrointestinal disease.
[7] Individuals with serious anemia.
[8] Individuals whose BMI is over 30 kg/m2.
[9] Individuals who are sensitive to test product or other foods, and medical products.
[10]Individuals who have a habit to ingest or use health-promoting foods, or supplements containing similar composition with a test food in the past 3 months or will ingest those foods during the test period.
[11] Individuals who are or are possibly pregnant, or are lactating.
[12] Individuals who excessively take alcohol.
[13] Individuals who are patient or have a history of psychiatric disease.
[14] Individuals who are a smoker.
[15] Individuals who work in sales or delivery, and who engage in outdoor activities and are exposed UV radiation in their daily lives.
[16] Individuals with possible changes of life style during the test period.
[17] Individuals who will develop seasonal allergy symptoms like hay fever and use a drug.
[18] Individuals who neglect skin care.
[19] Individuals who will get sunburned during the test period.
[20] Individuals who had been conducted an operation or beauty treatment on the test spot in the past 6 months.
[21] Individuals who participated in other clinical studies in the past 3 months.
[22] Individuals judged inappropriate for the study by the principal.
39
1st name | Takahiro |
Middle name | |
Last name | Ono |
Ueno-Asagao Clinic
Head
110-0015
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6240-1162
info@ueno-asagao.clinc
1st name | Ryoma |
Middle name | |
Last name | Shimizu |
TES Holdings Co., Ltd.
Administrative Department of Clinical Trials
110-0015
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6801-8480
r.shimizu@tes-h.co.jp
TES Holdings Co., Ltd.
S&B FOODS INC.
Profit organization
Ueno-Asagao Clinic Ethical Review Committee
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6240-1162
i.takahashi@tes-h.co.jp
NO
2023 | Year | 04 | Month | 17 | Day |
Unpublished
Completed
2021 | Year | 12 | Month | 27 | Day |
2022 | Year | 01 | Month | 20 | Day |
2022 | Year | 02 | Month | 18 | Day |
2022 | Year | 04 | Month | 18 | Day |
2022 | Year | 02 | Month | 07 | Day |
2022 | Year | 11 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053369
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |