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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036723
Receipt No. 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 2019/06/07

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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
Email 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
Email n-yuzawa@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

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
Email 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
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 No longer recruiting
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
2019 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041843

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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