UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056126 |
|---|---|
| Receipt number | R000063785 |
| Scientific Title | Efficacy evaluation of a food ingredient to skin condition in healthy adults -Randomized, double-blind, placebo-controlled, parallel-group study- |
| Date of disclosure of the study information | 2024/11/13 |
| Last modified on | 2024/10/18 14:52:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy evaluation of a food ingredient to skin condition in healthy adults
-Randomized, double-blind, placebo-controlled, parallel-group study-
Acronym
Efficacy evaluation of a food ingredient to skin condition
Scientific Title
Efficacy evaluation of a food ingredient to skin condition in healthy adults
-Randomized, double-blind, placebo-controlled, parallel-group study-
Scientific Title:Acronym
Efficacy evaluation of a food ingredient to skin condition
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of oral administration of a food ingredient on skin condition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin moisture
Key secondary outcomes
Evaluation of skin condition
Blood biochemical analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intakes of test capsules for 8 weeks
Interventions/Control_2
Intakes of placebo capsules for 8 weeks
Interventions/Control_3
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Male and Female aged from 30 to 69 years, when giving the informed consent.
2.Healthy individuals not having any chronic diseases.
3.Subjects who are concerned about decrease of moisture with skin aging.
4.Subjects who are concerned about dullness and uneven skin tone with skin aging.
5.Subjects who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
6.Individuals who can accomplish their tasks in the study at the appointed date.
7.Individuals who are judged suitable for this study by the investigator.
Key exclusion criteria
Subjects
1.who have some diseases with drug therapy.
2.who consecutively receive medications in the last 1 month.
3.who have severe disease histories in liver or the other tissues.
4.who have a comorbidity or disease history in respiratory system.
5.Systolic and diastolic blood pressures are over 160 mmHg and 100 mmHg, respectively.
6.who have donated over 200 or 400 mL of blood in the last 1 or 3 months.
7.who have severe anemia.
8.who could have some allergy to the test diet.
9.who are pregnant, breastfeeding, or planning to be pregnant in the near future.
10.who are alcoholic or have mental disorder.
11.who have a smoking habit.
12.who have irregular defecation.
13.who could change their life style during the study.
14.whose skin is extremely sensitive, or who have chronic ruddy complexion, outstanding pores or freckles.
15.who have some skin diseases.
16.who could have a seasonal allergy.
17.who have severe menopausal symptoms.
18.who have severe poor circulation.
19.who habitually shave their face with a razor blade.
20.who are willing to get sunburn, spend long time outdoors, during the study.
21.who habitually intake functional foods that could get skin condition better in the last 3 months.
22.who habitually consume cosmetics or foods made of microbes.
23.who routinely use pharmaceuticals that could get skin condition better.
24.who use cosmetics that could have strong effects on skin moisture or wrinkles.
25.who received a surgery on their faces or arms in the last 6 months.
26.who participated in other clinical trials in the last 3 months.
27.who and whose family work for a company manufacturing or selling healthy foods, functional foods or cosmetics.
28.who have a weakened immune system.
29.who refuse to disclose their biological sex.
30.who are judged unsuitable for this study by the investigator for other reasons.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Usida |
Organization
Kirin Holdings Company, Limited
Division name
Institute of Health Sciences
Zip code
251-8555
Address
Shonan-health-innovation-park 26-1 Muraoka-Higashi 2-chome Fujisawa Kanagawa Japan
TEL
080-1930-9932
Yusuke_Ushida@kirin.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo, 110-0015 JAPAN
TEL
03-6801-8480(+81-3-6801-8480)
Homepage URL
r.shimizu@tes-h.c.jp
Sponsor or person
Institute
TES Holdings Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kirin Group
Address
4-10-2, Nakano, Nakano-ku, Tokyo
Tel
03-6837-4128
02976_Ni@kirin.co.jp
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
うえのあさがおクリニック (東京都)/ Ueno-Asagao Clinic
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063785
