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

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

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284

TEL

050-3182-0593

Homepage URL

http://www.suntory.co.jp/sic/

Email

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


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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name