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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001493
Receipt No. R000001787
Scientific Title Effects of extract of decaffeinated green coffee beans on postprandial serum glucose in healthy subjects.
Date of disclosure of the study information 2008/11/10
Last modified on 2008/11/10

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Basic information
Public title Effects of extract of decaffeinated green coffee beans on postprandial serum glucose in healthy subjects.

Acronym Effects of extract of decaffeinated green coffee beans on postprandial serum glucose in healthy subjects.
Scientific Title Effects of extract of decaffeinated green coffee beans on postprandial serum glucose in healthy subjects.

Scientific Title:Acronym Effects of extract of decaffeinated green coffee beans on postprandial serum glucose in healthy subjects.
Region
Japan

Condition
Condition hyperglycemia
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the influence of extract of decaffeinated green coffee beans on postprandial glucose and insulin responses in subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Postprandial serum glucose (0,30,60,90, and 120min) and AUC (0-120min)
2) Postprandial serum insulin (0,30,60,90, and 120min) and AUC (0-120min)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 1) A total of 41 subjects (22 men and 19 women ) without type 2 diabetes were enrolled in the present study.
2) Test meals of 200g of a carbohydrate-rich meal plus placebo (200ml) were administered in a double-blind trial.
3) Antecubital venous blood was collected before the meal and at t = 0.5, 1, 1.5 and 2 h, where t = 0 was the start of test meal ingestion.
Interventions/Control_2 1) A total of 41 subjects (22 men and 19 women ) without type 2 diabetes were enrolled in the present study.
2) Test meals of 200g of a carbohydrate-rich meal plus extract of decaffeinated green coffee beans (100mg/200ml water) were administered in a double-blind trial.
3) Antecubital venous blood was collected before the meal and at t = 0.5, 1, 1.5 and 2 h, where t = 0 was the start of test meal ingestion.
Interventions/Control_3 1) A total of 41 subjects ( 22 men and 19 women ) without type 2 diabetes were enrolled in the present study.
2) Test meals of 200g of a carbohydrate-rich meal plus extract of decaffeinated green coffee beans (300mg/200ml water) were administered in a double-blind trial.
3) Antecubital venous blood was collected before the meal and at t = 0.5, 1, 1.5 and 2 h, where t = 0 was the start of test meal ingestion.
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
50 years-old >
Gender Male and Female
Key inclusion criteria 1) Healthy men and women over 20 years old and under 50 years old.
2) Individuals who can abstain from before the experiment.
3) Individuals who understand the purpose and contents of the experiment.
4) Individuals to be suitable by the doctor.
Key exclusion criteria 1) Individuals who do not usually eat breakfast.
2) Individuals taking drugs which affect the glucose level.
3) Individuals taking supplements which improve the glucose level.
4) Individuals judged to have diabetes mellitus.
5) Individuals with serious complications or with a disease which urgently needs treatment.
6) Individuals with a chronic disease.
7) Individuals with a digestive system disease and with a history of digestive organ surgery.
8) Individuals with a medical record of drug or alcohol dependence.
9) Pregnant women, or women with intending to become pregnant, and lactating women.
10) Individuals participating or intending to participate in a drug administration test.
11) Individuals judged by the doctor to be unsuitable.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taiji FUKUNAGA
Organization UCC Ueshima Coffee, Co., Ltd.
Division name R&D center
Zip code
Address 3-1-4, Zushi, Takatsuki-shi, Osaka,Japan 569-0036
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya IWAI
Organization UCC Ueshima Coffee, Co., Ltd.
Division name R&D center
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute UCC Ueshima Coffee, Co., Ltd.
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2008 Year 11 Month 10 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
2007 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2007 Year 05 Month 01 Day
Last follow-up date
2007 Year 08 Month 01 Day
Date of closure to data entry
2008 Year 11 Month 01 Day
Date trial data considered complete
2008 Year 11 Month 01 Day
Date analysis concluded
2008 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 11 Month 10 Day
Last modified on
2008 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001787

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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