UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031682 |
|---|---|
| Receipt number | R000029575 |
| Scientific Title | Clinical trials to evaluate the effectiveness of lingonberry and amla fruit extract intake |
| Date of disclosure of the study information | 2018/03/14 |
| Last modified on | 2018/06/15 08:37:33 |
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Basic information
Public title
Clinical trials to evaluate the effectiveness of lingonberry and amla fruit extract intake
Acronym
Clinical trials to evaluate the effectiveness of lingonberry and amla fruit extract intake
Scientific Title
Clinical trials to evaluate the effectiveness of lingonberry and amla fruit extract intake
Scientific Title:Acronym
Clinical trials to evaluate the effectiveness of lingonberry and amla fruit extract intake
Region
| Japan |
Condition
Condition
The healthy female who feels decline of the skin condition
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of improving skin condition by the intake of lingonberry and amla fruit extract is evaluated in a randomized, double-blind, placebo-controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The elasticity of the skin is measured four times for 12 weeks every four weeks.
Key secondary outcomes
The following measurement item is measured four times for 12 weeks every four weeks.
1. Skin thickness
2. Stratum corneum hydration
3. Epidermal and dermal hydration
4. Clinical evaluation of wrinkle
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
In the placebo group, the placebo drink must take in every day for 12 weeks.
The placebo beverage is prepared with the same amounts of sweetener, sour seasoning and flavor as test beverage, so that they will not differ in taste from each other.
Interventions/Control_2
The test beverage of "the lingonberry and amla fruit extract (LAE) single dose drink" must take in every day for 12 weeks.
Interventions/Control_3
The test beverage of "LAE double dose drink" must take in every day for 12 weeks.
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
| 35 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Healthy females from 35 years old to 50 years old
2.Individuals conscious of skin roughness by drying
3.Individuals who has felt an effect on skin by the intake of the supplement
4.Individuals who feels a decrease of the elasticity of the skin
5. Individuals who does not use a supplement and a drug regularly now
6. Individuals who abstain from drinking alcohol from the day before measurement to the measurement end
7. Individuals who agree to participate in the study
8. Individuals judged appropriate for the study by attendant physician
Key exclusion criteria
1.Individuals with abnormalities of skin areas planned to be tested
2.Individuals considered likely to develop allergy to the test substance (Individuals with food allergy)
3.Individuals with chronic cutis symptoms such as atopic dermatitis
4.Patients receiving drug therapy as outpatients
5.Individuals participating in other studies within the past 3 months
6.Habitual smokers
7.Patients with asthma
8.Pregnant women, women desiring to become pregnant, or lactating women
9.Individuals having used cosmetics or the like possessing moisture-retaining effects on the skin areas planned to be tested in this study within 1 month before the start of the study
10.Individuals taking or intending to take drugs against pollinosis
11.Individuals judged inappropriate for the study by attending physician
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Ogo |
Organization
SHISEIDO CO., LTD.
Division name
Life Science Reserch Center
Zip code
Address
2-2-1,Hayabuchi,Tsuzuki-ku, YOKOHAMA, KANAGAWA-ken 224-0025, Japan
TEL
045-590-6000
masashi.ogo@to.shiseido.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Takashima |
Organization
Inforward, Inc
Division name
Ebisu Skin Research Center
Zip code
Address
1-11-2 Ebisu, Shibuya, Tokyo 1500013, Japan
TEL
03-5447-6411
Homepage URL
takashima@inforward.co.jp
Sponsor or person
Institute
SHISEIDO CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2018 | Year | 03 | Month | 14 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 05 | Month | 19 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 20 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 12 | Day |
Last modified on
| 2018 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029575
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
