UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001493 |
|---|---|
| Receipt number | 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 12:14:57 |
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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
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
Sponsor or person
Institute
UCC Ueshima Coffee, Co., Ltd.
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001787
