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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016221
Receipt No. R000018823
Scientific Title A study on the effect of bitter gourd (Momordica charantia) containing drink on blood glucose level in human.
Date of disclosure of the study information 2015/02/01
Last modified on 2015/01/15

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Basic information
Public title A study on the effect of bitter gourd (Momordica charantia) containing drink on blood glucose level in human.
Acronym A study on the effect of bitter gourd (Momordica charantia) containing drink on blood glucose level in human.
Scientific Title A study on the effect of bitter gourd (Momordica charantia) containing drink on blood glucose level in human.
Scientific Title:Acronym A study on the effect of bitter gourd (Momordica charantia) containing drink 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 bitter gourd containing drink on blood glucose level after ingestion of rice in human.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

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

Base
Study type Interventional

Study design
Basic design Cross-over
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 5
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 cellulose
Interventions/Control_2 bitter gourd beverage, low dose (cultivar A, the amount of bitter gourd=50g)
Interventions/Control_3 bitter gourd beverage, high dose (cultivar A, the amount of bitter gourd=100g)
Interventions/Control_4 bitter gourd beverage, low dose (cultivar B, the amount of bitter gourd=50g)
Interventions/Control_5 bitter gourd beverage, high dose (cultivar B, the amount of bitter gourd=100g)
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 constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
(3)Subjects who have contracted or are contracting heart disease, liver disease, kidney disease and digestive disease.
(4)Subjects who are pregnant or have possibility to bocome pregnant or planning to become pregnant during the study or breast-feeding woman.
(5)Subjects who drink alcohol a lot
(6)Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift
(7)Subjects who have allergic reaction to drug medicine and food.
(8)Subjects who have systolic blood pressure less than 90 mmHg.
(9)Subjects who donated 200 mL of blood and/or blood components within the last one month prior to the current study.
(10)Male subjects who donated 400 mL of blood within the last three months prior to the current study.
(11)Female subjects who donated 400 mL of blood within the last four months prior to the current study.
(12)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.
(13)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.
(14)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.
(15)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size 20

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 1-1-1 Wakayamadai, Shimamoto-cho, Mishima-gu, Osaka
TEL 075-962-4853
Email 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 1-1-1 Wakayamadai, Shimamoto-cho, Mishima-gu, Osaka
TEL 075-962-7599
Homepage URL
Email H_Watanabe@suntory.co.jp

Sponsor
Institute Suntory Global Innovation Center Limited
Institute
Department

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
Email

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 02 Month 01 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
2014 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 23 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 01 Month 15 Day
Last modified on
2015 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018823

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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