UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026636
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Imagine Global Care
Institute
Department

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
URL(English) https://upload.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


Contact us.