UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017737 |
|---|---|
| Receipt number | R000020547 |
| Scientific Title | Effect of the long-term intake of bitter gourd (Momordica charantia) containing food on blood glucose level in human. |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2016/01/07 09:29:28 |
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Basic information
Public title
Effect of the long-term intake of bitter gourd (Momordica charantia) containing food on blood glucose level in human.
Acronym
Effect of the long-term intake of bitter gourd (Momordica charantia) containing food on blood glucose level in human.
Scientific Title
Effect of the long-term intake of bitter gourd (Momordica charantia) containing food on blood glucose level in human.
Scientific Title:Acronym
Effect of the long-term intake of bitter gourd (Momordica charantia) containing food on blood glucose level in human.
Region
| Japan |
Condition
Condition
high normal blood glucose and borderline hyperglycemia
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of 12-week intake of bitter gourd containing beverages on blood glucose level.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of blood glucose level after ingestion of rice
Key secondary outcomes
Blood glucose level at each blood sampling time after ingestion of rice, Active blood GLP-1 level, IRI, Fasting blood glucose level, HOMA-IR
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake 250ml of bitter gourd containing beverage for 12 weeks once a day
Interventions/Control_2
Intake 250ml of polydextrose for 12 weeks once a day
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy males and females aged 20 to less than 65 years old.
(2)Subjects whose fasting blood glulose levels are ranged from 100mg/dL to less than 126 mg/dL.
(3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1)Subjects who take continuous medical treatment.
(2)Subjects who are contracting diabetes (based on diagnosis criterion of The Japan Diabetes Society)
(3)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
(4)Subjects who have contracted or are contracting heart disease, liver disease, kidney disease and digestive disease.
(5)Subjects who are pregnant or have possibility to bocome pregnant or planning to become pregnant during the study or breast-feeding woman.
(6)Subjects who drink alcohol a lot
(7)Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift
(8)Subjects who have allergic reaction to drug medicine and food.
(9)Subjects who have systolic blood pressure less than 90 mmHg.
(10)Subjects who donated 200 mL or more of blood and/or blood components within the last one month prior to the current study.
(11)Male subjects who donated 400 mL or more of blood within the last three months prior to the current study.
(12)Female subjects who donated 400 mL or more of blood within the last four months prior to the current study.
(13)Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added.
(14)Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added.
(15)Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks, or who are planning to participate in other clinical study.
(16)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Abe |
Organization
Suntory Global Innovation Center Limited
Division name
Innovation Development Department
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284
TEL
0774-66-1110
Keiichi_Abe@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Watanabe |
Organization
Suntory Global Innovation Center Limited
Division name
Innovation Development Department
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284
TEL
050-3182-0593
Homepage URL
http://www.suntory.co.jp/sic/
H_Watanabe@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center Limited
Institute
Department
Personal name
Funding Source
Organization
National Agricultural and Food Research Organization
Organization
Division
Category of Funding Organization
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
YES
Study ID_1
13413790
Org. issuing International ID_1
National Agricultural and Food Research Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 25 | 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
| 2015 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 08 | 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
| 2015 | Year | 05 | Month | 29 | Day |
Last modified on
| 2016 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020547
