Unique ID issued by UMIN | UMIN000025759 |
---|---|
Receipt number | R000029632 |
Scientific Title | A systematic review on the improvement of skin moisture retention by the functional participating component "glucosylceramide" |
Date of disclosure of the study information | 2017/01/20 |
Last modified on | 2017/02/08 09:47:10 |
A systematic review on the improvement of skin moisture retention by the functional participating component "glucosylceramide"
A systematic review on the improvement of skin moisture retention by the functional participating component "glucosylceramide"
A systematic review on the improvement of skin moisture retention by the functional participating component "glucosylceramide"
A systematic review on the improvement of skin moisture retention by the functional participating component "glucosylceramide"
Japan |
Clinical research paper carried out on healthy subjects not suffering from skin diseases
Dermatology | Aesthetic surgery | Adult |
Others
NO
From clinical studies conducted on healthy subjects not suffering from skin diseases, clinical research papers were orally ingested by plant-derived glucosylceramide by a systematic analysis method "Systematic Review" We will carry out comprehensive evaluation and verification of effectiveness and safety concerning skin moisture retention (transepidermal water dissipation amount, stratum corneum water content etc.).
Safety,Efficacy
Evaluate the influence of continuous ingestion of food-derived functional ingredient "glucosylceramide" on skin moisturizing
Others,meta-analysis etc
20 | years-old | <= |
Not applicable |
Male and Female
[PICOS]
(Patients)
Clinical study conducted in Japan for persons not suffering from skin diseases
(Interventions)
1. Ongoing intake of glucosylceramide containing supplements
2. Continuous intake of food containing glucosylceramide
(Control)
as a control composition (control group)
1. Supplements not containing glucosylceramide
2. Foods not containing glucosylceramide
(Outcome)
Continuous uptake of glucosylceramide improves skin moisturizing function
(Example)
1. Evaluation by medical consultation, interview, palpation, visual inspection etc.
2. Measured values such as percutaneous water transpiration amount, horny layer water content
(Study design)
Placebo or non glucosylceramide as control
1. Double blind parallel group comparison test
2. Single blind parallel group comparison test
3. Double blind crossover comparative test
4. Single blind crossover comparison test
Contains glucosylceramide
1. Dose setting test
2. Gradual increase / decrease test
[Selection criteria (eligibility criteria)]
In the primary screening, among the candidate literatures assumed to be clinical studies concerning the oral intake of plant-derived glucosiceramide targeted to Japanese conducted in Japan by the abstract of Medical Magazine WEB, the following selection criteria Criteria), one corresponding to one or more is taken as a temporary candidate document.
1. Clinical research literature for domestic non-affected persons with skin
2. Literature of clinical research for adults conducted in Japan
3. Clinical research literature extracted by medical magazine WEB of literature retrieval system
4. Clinical research literature conducted by public institutions
5. Clinical research literature published by National Institute of Research and Technology Agriculture Food Industry Research Organization (Agricultural Research Organization)
6. Clinical research literature adopted by the reviewer's agreement besides the medical magazine WEB
[Exclusion Criteria]
In the secondary screening, provisional candidate documents are obtained by the abstract, and those corresponding to one or more of the following exclusion criteria are excluded from the candidate literature.
1. Clinical research literature for subjects suffering from skin diseases
2. Literature of clinical research for minors
3. Clinical research literature for pregnant women and lactating women
4. Clinical research literature not reviewed
5. Literature of clinical study without comparative control group
6. Literature of clinical study in which the main involved component is not glucosylceramide
7. Clinical research literature which can not be evaluated by glucosylceramide and other equivalent ingredients
8. In addition, clinical research literature judged inappropriate by the reviewer's agreement
1
1st name | |
Middle name | |
Last name | Toru Urakawa |
Adaptgen Pharmaceutical Co., Ltd.
Sales Planning Division & Clinical development division
1-90-1, Kamiyama-cho, Tajimi-shi, Gifu, 5070022, Japan
0572-56-1111
adurakawa@adaptgen.co.jp
1st name | |
Middle name | |
Last name | Toru Urakawa |
Adaptgen Pharmaceutical Co., Ltd.
Sales Planning Division & Clinical development division
1-90-1, Kamiyama-cho, Tajimi-shi, Gifu, 5070022, Japan
0572-56-1111
adurakawa@adaptgen.co.jp
Adaptgen Pharmaceutical Co., Ltd.
Adaptgen Pharmaceutical Co., Ltd.
Profit organization
NO
2017 | Year | 01 | Month | 20 | Day |
Unpublished
Relationship between the results of research review and the functionality to be displayed
As a result of the SR study, the outcome with respect to the RQ / QC set for the functionality (effectiveness) given to a person by the functional participating component glucosylceramide is to consume glucosylceramide continuously from 0.6 mg to 4.0 mg per day By improving the barrier function of the skin and water retention ability and improving the moisturizing function "as confirmed by this SR research, the ancestor and divergence between the display contents and the literature It can be denied. Also regarding safety, there were no adverse events that glucosylceramide is considered to be a direct cause, and certain safety was also confirmed.
Completed
2017 | Year | 01 | Month | 16 | Day |
2017 | Year | 01 | Month | 20 | Day |
2017 | Year | 02 | Month | 08 | Day |
2017 | Year | 02 | Month | 08 | Day |
(Data extraction process)
In Adaptogen Pharmaceutical Co., Ltd., "Guidelines on Notification of Functional Displayed Foods" and "Ethical Guidelines on Medical Research for Human Subjects" notified by regulatory authorities in accordance with the Functionally Displayed Food System, and other related laws, guidelines, and guidelines Based on the notification, "Standard Operating Procedure for Functionally Displayed Food etc." was established and the evaluation verification method by the systematic analysis method "Systematic Review" of the clinical research paper and the revision of the patent law (April 1, 2016) Provisions and procedures have been established and operated taking intellectual property rights (patent rights, utility model rights, design rights, trademark rights, copyrights, unfair competition prevention laws and related laws) into consideration.
(Reliability and Evaluation Criteria in Clinical Research)
About the evaluation of the bias risk that can be investigated with reference to "ethical guidelines on research on medical science for human beings" and GCP ministerial ordinance, Collaboration , Clinical trials including clinical physicians, clinical trial investigations committee,ethical review committee, medical experts and experts in basic research field, and 14 bias risk evaluation items and individual research bias risk The comprehensive evaluation criteria of.
2017 | Year | 01 | Month | 20 | Day |
2017 | Year | 02 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029632