UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of bitter melon extract on postprandial blood glucose level, activation of immunity, and other biochemical indicators among healthy adults
Title of the study (Brief title)	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	Hiroki Kinoshita
Organization	Imagine Global Care
Division name	Research and Development
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	Keiko Takiguchi
Organization	Imagine Global Care
Division name	Research and Development
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030590