UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026636
Receipt number R000030590
Scientific Title Effects of bitter melon extract on postprandial blood glucose level, activation of immunity, and other biochemical indicators among healthy adults
Date of disclosure of the study information 2017/03/22
Last modified on 2017/09/29 10:57:50

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Basic information

Public title

Effects of bitter melon extract on postprandial blood glucose level, activation of immunity, and other biochemical indicators among healthy adults

Acronym

Effects of bitter melon extract on postprandial blood glucose level, activation of immunity, and other biochemical indicators among healthy adults

Scientific Title

Effects of bitter melon extract on postprandial blood glucose level, activation of immunity, and other biochemical indicators among healthy adults

Scientific Title:Acronym

Effects of bitter melon extract on postprandial blood glucose level, activation of immunity, and other biochemical indicators among healthy adults

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to examine the effects of a supplement containing bitter melon extract on postprandial blood glucose level

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluate blood glucose level 30,60,90,120 minutes after taking a rice ball and three tablets of supplement which contain bitter melon extract

Key secondary outcomes

Evaluate fasting blood glucose, Hemoglobin A1c, Total cholesterol, HDL cholesterol, LDL cholesterol,uric acid, NK cell activity, Neutrophil phagocytosis after taking three tablets /day for 30 days


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Group A is going to take three tablets of supplement which contains bitter melon extract for 30days

Interventions/Control_2

Group B is going to take three tablets of placebo for 30days

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

40 years-old <=

Age-upper limit

74 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Subjects aged between 40 years and 74 years old at the time obtaining consent
(2)Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study

Key exclusion criteria

(1)Subjects using medical products
(2)Subjects who could start having allergic symptom in relation to test products
(3) Subjects who use health food and supplements affecting clinical trial
(4) Subjects who had surgical removal of the digestive organs
(5) Subjects who are pregnant, breastfeeding, may be pregnant
(6)Subjects who participated in other clinical trials within the last three month prior to the current clinical trial
(7) Subjects judged inappropriate for the study by the investigator

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroki Kinoshita

Organization

Imagine Global Care

Division name

Research and Development

Zip code


Address

8F Roppongi KS building,3-16-12 Roppongi, Minato-ku, Tokyo

TEL

03-5549-2814

Email

hiroki-kinoshita@imagine-gc.com


Public contact

Name of contact person

1st name
Middle name
Last name Keiko Takiguchi

Organization

Imagine Global Care

Division name

Research and Development

Zip code


Address

8F Roppongi KS building,3-16-12 Roppongi, Minato-ku, Tokyo

TEL

03-5549-2814

Homepage URL

http://www.imagine-gc.com/

Email

keiko-takiguchi@imagine-gc.com


Sponsor or person

Institute

Imagine Global Care

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2017 Year 03 Month 22 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 03 Month 21 Day

Date of IRB


Anticipated trial start date

2017 Year 03 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 03 Month 22 Day

Last modified on

2017 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030590


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name