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
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/
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
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
