UMIN-CTR Clinical Trial

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

hyperglycemia

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

UCC Ueshima Coffee, Co., Ltd.

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

11

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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