UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036723 |
|---|---|
| Receipt number | R000041843 |
| Scientific Title | A test to find whether continuous test beverage taking has preventive effects on gray hair and efficacy for skin function. |
| Date of disclosure of the study information | 2019/05/15 |
| Last modified on | 2020/01/24 12:29:35 |
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Basic information
Public title
A test to find whether continuous test beverage taking has preventive effects on gray hair and efficacy for skin function.
Acronym
A test to find whether continuous test beverage taking has preventive effects on gray hair and efficacy for skin function.
Scientific Title
A test to find whether continuous test beverage taking has preventive effects on gray hair and efficacy for skin function.
Scientific Title:Acronym
A test to find whether continuous test beverage taking has preventive effects on gray hair and efficacy for skin function.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Males and females (aged 20-69), who are concerned about gray hair, take test beverage continuously for 16 weeks. Under this condition, we aim at examining preventive effects of test beverage on gray hair and efficacy of test beverage for skin function and bowel movement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessments of hair: black hair/gray hair ratios in measurement sites.
Key secondary outcomes
Telomere test; A questionnaire about bowel movement; Skin hydration, moisture, and elasticity; A questionnaire about the subjective symptoms of hair and skin conditions; Vascular density.
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Use the 20mL measuring cup provided and take approximately 20mL of test beverage per day.
Interventions/Control_2
Use the 20mL measuring cup provided and take approximately 20mL of placebo beverage per day.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. 20 to 69 years old (at the time of submission of an informed consent document).
2. Healthy individuals (those who were judged to be healthy by the principal investigator).
3. Males and females.
4. Those who are concerned about gray hair.
5. Smartphone users (who can input their own data into the electronic diary).
6. Those who do not intend to change or do not change everyday lifestyle habits during the study period.
7. Those who can take test beverage continuously for 4 months.
8. Those who can provide a written informed consent.
Key exclusion criteria
1. Those who are currently receiving some types of drug treatment (except for the drugs that are taken as needed).
2. Those who are receiving diet therapy or exercise therapy under the direction of a physician.
3. Those who have a past medical history of treatment for malignant tumor, heart failure, or heart attack.
4. Those who have undergone gastrointestinal surgery (except for appendectomy).
5. Those who have a past medical history of any of the following: hepatic or other major disorders (kidneys, endocrine, cardiovascular, gastrointestine, lungs, blood, and metabolism), or complications of the disorders listed above.
6. Those who have a past and current medical history of drug or food allergy.
7. Those who are currently taking health food (such as supplements or food products to maintain or restore health).
8. Those who work irregular hours (including those who work on the night shifts).
9. Smokers.
10. Those who had participated in another clinical trial conducted within a month prior to the submission of an informed consent document (including those who had taken test food during this study period).
11. Those who are currently pregnant or breastfeeding and those who want to become pregnant.
12. Those who were determined by the principal investigator to be unsuitable for participation in this study.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Nakamura |
Organization
Higashi Koganei Sakura Clinic
Division name
Chairman
Zip code
184-0011
Address
4-37-26,Higashicho,Koganei-shi,Tokyo
TEL
042-382-3081
higashikoganeisakura-clinic@imeq.co.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Yuzawa |
Organization
imeQ RD inc.
Division name
Sales department
Zip code
160-0051
Address
2-14-6, Nishi-Waseda, Shinjyuku, Tokyo
TEL
03-6225-6222
Homepage URL
n-yuzawa@imeqrd.co.jp
Sponsor or person
Institute
imeQ RD inc.
Institute
Department
Personal name
Funding Source
Organization
Kotohogi Co.,Ltd.
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
Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjyuku, Tokyo
Tel
03-6205-6222
suda-clinic_irb@imeq.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 15 | 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
44
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
| 2019 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 13 | Day |
Last modified on
| 2020 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041843
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