UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized control trial of Trapa japonica extract intake on anti-glycation effect and improvement in skin.
Title of the study (Brief title)	Anti-glycation effect of "Trapa japonica extract" on human skin.
Region	Japan

Condition
Condition	Healthy men and women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the anti-glyaction effect ond skin inmrovement by 12-week oral treatment of Trapa japonica extract.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin elasticity, corneum CML, skin AGEs accumulation, fasting plasma glucose, glycoalbumin, HDL-C, LDL-C, trglyceride, questionnaire
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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	Test group Oral intake of capsules with 100mg Trapa japonica extract before breakfast for 12 weeks
Interventions/Control_2	Control group Oral intake of capsules without Trapa japonica extract before breakfast for 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy Japanese men and women ages 20 or more and less than 70 years old
Key exclusion criteria	1) Users of anti-glycation materials 2) Users of medicines or supplements affecting blood glucose 3) Persons with severe dysfunction of liver, kidney or heart 4) Persons with food allergy or allergic dermatitis 5) Persons who received gastrointestinal surgery
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshikazu Yonei
Organization	Graduate School of Life and Medical Sciences, Doshisha University
Division name	Anti-Aging Medical Research Center
Address	1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL	0774-65-6394
Email	yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person	Yoshika Ishioka
Organization	Graduate School of Life and Medical Sciences, Doshisha University
Division name	Anti-Aging Medical Research Center
Address	1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL	0774-65-6382
Homepage URL
Email	ishiyoshi.2.13@gmail.com

Sponsor
Institute	Anti-Aging Medical Research Center, Graduate School of Life and Medical Sciences, Doshisha University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Hayashikane Sangyo 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	2014 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 29 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2015 Year 09 Month 01 Day
Date of closure to data entry	2015 Year 09 Month 01 Day
Date trial data considered complete	2015 Year 09 Month 01 Day
Date analysis concluded

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

Management information
Registered date	2014 Year 09 Month 01 Day
Last modified on	2016 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017462