UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of the Test Food on Anti-Glycative Actions, Skin Quality and Endothelial Function
Title of the study (Brief title)	Effect of the Test Food on Anti-Glycative Actions, Skin Quality and Endothelial Function
Region	Japan

Condition
Condition	N/A (healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate effect of the test food on anti-glycative actions, skin quality and endothelial function.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Skin quality evaluation (Transepidermal water loss, skin moisture content, skin viscoelasticity, image analysis by VISIA, observation for skin condition by dermatologists), anti-glycation evaluation (Skin AGEs deposition, blood pentosidine), and vascular endothelial evaluation (acceleration pulse wave, arterial pressure-volume index, arterial velocity pulse index). (1) Week 0, Week 4, Week 8, Week 12 (image analysis of Visia will be held in Week 0 and Week 12).
Key secondary outcomes	*Safety [1]Blood pressure, pulsation (Week 0, Week 4, Week 8, Week 12) [2]Weight, body fat percentage, BMI (Week 0, Week 4, Week 8, Week 12) [3]Blood test (Week 0, Week 4, Week 8, Week 12) [4]Blood biochemical test (Week 0, Week 4, Week 8, Week 12) [5]Urine analysis (Week 0, Week 4, Week 8, Week 12) [6]Doctor's questions (Week 0, Week 4, Week 8, Week 12) *Other index [1]Subject's diary (From the first day of ingestion of a test material to the last day of the test)

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	Treatment
Type of intervention	Food
Interventions/Control_1	Oral intake of the test food (1 time in a day, 12 weeks)
Interventions/Control_2	Oral intake of the placebo food (1 time in a day, 12 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	20 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	[1]Females aged 20-59 years. [2]Individuals who are healthy and have no chronic physical disease including skin disease. [3]Individuals who are concerning on skin sagging and dullness. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can have an examination in a designated day. [6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals using medical products. [2]Individuals who used or applied a drug for treatment of disease in the past 1 month. [3]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [4]Individual who have digestive organ disease. [5]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg. [6]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [7]Individuals with serious anemia. [8]Individuals who are sensitive to test product or other foods, and medical products. [9]Individuals who are or are possibly pregnant, or are lactating. [10]Individuals who have an addiction to alcohol or a mental illness. [11]Individuals who are a smoker. [12]Individuals whose bowel habit is irregular. [13]Individuals with possible changes of life style during the test period. [14]Individuals whose skin is sensitive or who is a chronic red face. [15]Individuals with skin disease, such as atopic dermatitis. [16]Individuals with probable seasonal allergy during the test period. [17]Individuals who are sensitive to cold. [18]Individuals who are busy to their own work, housework or child care and neglect skin care. [19]Individuals who cannot avoid daylight exposure during the test period. [20]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [21]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [22]Individuals who use cosmetics having a strong moisturizing effect or improving effect for wrinkle. [23]Individuals who had been conducted an operation on the test spot in the past 6months. [24]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [25]Individuals judged inappropriate for the study by the principal.
Target sample size	40

Research contact person
Name of lead principal investigator	Shuji Nakata
Organization	Medical Corporation Bokushinkai CLINTEXE Clinic
Division name	Head
Address	4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL	+81-3-5405-1059
Email	info@tes-h.co.jp

Public contact
Name of contact person	Ryoma Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	Nippon Shinyaku Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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 04 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 08 Day
Anticipated trial start date	2016 Year 01 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 19 Day
Last modified on	2018 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036755