UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on effect of the drinking vinegar which blended a mangosteen extract on postprandial blood glucose levels.
Title of the study (Brief title)	A Study on effect of the drinking vinegar which blended a mangosteen extract on postprandial blood glucose levels.
Region	Japan

Condition
Condition	Postprandial hyperglycemia
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to investigate the effect of take the drinking vinegar which blended a mangosteen extract on postprandial hyperglycemia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postprandial blood glucose (0,15,30,45,60,90 and 120min)
Key secondary outcomes	Postprandial Insulin (0,15,30,45,60,90 and 120min) Postprandial Glucagon (0,15,30,45,60,90 and 120min) Postprandial Triglyceride (0,15,30,45,60,90 and 120min) Non-esterified fatty acid (0,15,30,45,60,90 and 120min)

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	active food
Interventions/Control_2	placebo food
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Aged between 20 and 49 [2]Individuals who are healthy and do not treat any disease [3]Individuals who feels that a blood sugar level is rather high [4]Individuals whose written informed consent has been obtained [5]Individuals who can have an examination on a designated check day [6]Individuals judged appropriate for the study by the principal
Key exclusion criteria	[1]Individuals using medical products [2]Individuals who are or are under treatment or have a history of Impaired Glucose Tolerance,mental disabilities,sleep disorder,hypertension,diabetes,fat metabolism or the other serious dysfunctions [3]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it.) [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease,or blood disease [5]Individual who have digestive organ disease(disease of an appendix is removed) [6]Individuals whose BMI is over 30 kg/m2 [7]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [8]Individuals with serious anemia [9]Individuals who are sensitive to test products or Individual with fear who causes severe allergy in a food and medical supplies [10]Individual who is pregnant or lactate [11]Individual who is based on average alcohol per 1 day and exceeds 60g/day [12]Individuals whose life style will change during the test period (ex. travel for a long time) [13]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments of glycometabolism in the past 3 month or will ingest those foods during the test period [14]Individuals who participated in other clinical studies in the past three months [15]Individuals judged inappropriate for the study by the principal
Target sample size	24

Research contact person
Name of lead principal investigator	Yoshikazu Yonei
Organization	Doshisha University
Division name	Graduate School of Life and Medical Sciences
Address	1-3 Tatara Miyakodani Kyotanabe City Kyoto, 610-0394, Japan
TEL	0774-65-6394
Email	yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	info@tes-h.co.jp

Sponsor
Institute	Anti-Aging Bank Co.,Ltd.
Institute
Department

Funding Source
Organization	YOMEISHU SEIZO 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	医療法人相生会　墨田病院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 17 Day
Anticipated trial start date	2016 Year 06 Month 21 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	2016 Year 06 Month 21 Day
Last modified on	2017 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026280