UMIN-CTR Clinical Trial

Public title

A Study on effect of the drinking vinegar which blended a mangosteen extract on postprandial blood glucose levels.

Acronym

A Study on effect of the drinking vinegar which blended a mangosteen extract on postprandial blood glucose levels.

Scientific Title

A Study on effect of the drinking vinegar which blended a mangosteen extract on postprandial blood glucose levels.

Scientific Title:Acronym

A Study on effect of the drinking vinegar which blended a mangosteen extract on postprandial blood glucose levels.

Region

Japan

Condition

Postprandial hyperglycemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yoshikazu Yonei

Organization

Doshisha University

Division name

Graduate School of Life and Medical Sciences

Zip code

Address

1-3 Tatara Miyakodani Kyotanabe City Kyoto, 610-0394, Japan

TEL

0774-65-6394

Email

yyonei@mail.doshisha.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshiyasu Tamura

Organization

TES Holdings Co., Ltd.

Division name

Department of Clinical Trial

Zip code

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

Institute

Anti-Aging Bank Co.,Ltd.

Institute

Department

Personal name

Organization

YOMEISHU SEIZO Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人相生会　墨田病院（東京都）

Date of disclosure of the study information

2016

Year

06

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

06

Month

17

Day

Date of IRB

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

Other related information

Registered date

2016

Year

06

Month

21

Day

Last modified on

2017

Year

01

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026280