UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trials to evaluate the effectiveness of lingonberry and amla fruit extract intake
Title of the study (Brief title)	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	Masashi Ogo
Organization	SHISEIDO CO., LTD.
Division name	Life Science Reserch Center
Address	2-2-1,Hayabuchi,Tsuzuki-ku, YOKOHAMA, KANAGAWA-ken 224-0025, Japan
TEL	045-590-6000
Email	masashi.ogo@to.shiseido.co.jp

Public contact
Name of contact person	Kazunori Takashima
Organization	Inforward, Inc
Division name	Ebisu Skin Research Center
Address	1-11-2 Ebisu, Shibuya, Tokyo 1500013, Japan
TEL	03-5447-6411
Homepage URL
Email	takashima@inforward.co.jp

Sponsor
Institute	SHISEIDO CO., LTD.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029575