UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020594
Receipt number R000023774
Scientific Title Intervention study on prevention of lifestyle-related diseases by continuous coffee beverage consumption
Date of disclosure of the study information 2016/01/19
Last modified on 2019/08/22 15:50:41

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Basic information

Public title

Intervention study on prevention of lifestyle-related diseases by continuous coffee beverage consumption

Acronym

Intervention study on prevention of lifestyle-related diseases by continuous coffee beverage consumption

Scientific Title

Intervention study on prevention of lifestyle-related diseases by continuous coffee beverage consumption

Scientific Title:Acronym

Intervention study on prevention of lifestyle-related diseases by continuous coffee beverage consumption

Region

Japan


Condition

Condition

Persons with obesity or with high-normal blood pressure or mild hypertension

Classification by specialty

Cardiology Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To test whether consumption of coffee beverage for 12 weeks decrease visceral fat area.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Changes in visceral fat area at the time participants finished drinking coffee beverage for 12 weeks

Key secondary outcomes

Changes in blood pressure, body weight, body mass index, abdominal circumference, AST, ALT, GGTP, Total cholesterol, HDL-cholestrerol, LDL-cholestrerol, triglyceride, fasting blood glucose, HbA1c, uric acid, glycoalbumin at the time participants finished drinking coffee beverage for 12 weeks


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Observe changes in visceral fat area after consumption of coffee beverage for 12 weeks.

Interventions/Control_2

Observe changes in visceral fat area after consumption of placebo beverage for 12 weeks.

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

BMI >= 25kg/m2, or persons with high-normal blood pressure or with mild hypertension.
Those who are not taking medicine

Key exclusion criteria

Persons with severe liver damage, kidney and heart disease, oragan damage, diabetes, food allergy or other serious diseases.

Target sample size

180


Research contact person

Name of lead principal investigator

1st name Tatsuya
Middle name
Last name Takeshita

Organization

Wakayama Medical University

Division name

Department of Public Health

Zip code

641-8509

Address

811-1 Kimiidera, Wakayama city, Wakayama 641-8509, Japan

TEL

+81-73-441-0647

Email

ttakeshi@wakayama-med.ac.jp


Public contact

Name of contact person

1st name Tatsuya
Middle name
Last name Takeshita

Organization

Wakayama Medical University

Division name

Department of Public Health

Zip code

641-8509

Address

811-1 Kimiidera, Wakayama city, Wakayama 641-8509, Japan

TEL

+81-73-441-0647

Homepage URL


Email

ttakeshi@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayama Medical University, Graduate School of Health and Nursing Sciences

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Wakayama Medical University IRB

Address

811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan

Tel

+81-73-447-2300

Email

wa-rinri@wakayama-med.ac.jp


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

和歌山市役所、かつらぎ町役場、北出病院


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 19 Day


Related information

URL releasing protocol

Unpublished due to the protocol including the intellectual property rights

Publication of results

Unpublished


Result

URL related to results and publications

works in progress

Number of participants that the trial has enrolled

84

Results

There were no significant results for the primary endpoint.

Results date posted

2019 Year 08 Month 08 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy men and women

Participant flow

Preliminary screening for 150 people
84 people included
84 people analyzed

Adverse events

No adverse effect related to the test diets reported

Outcome measures

Metabolic parameters

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2015 Year 12 Month 11 Day

Date of IRB

2015 Year 09 Month 30 Day

Anticipated trial start date

2016 Year 01 Month 19 Day

Last follow-up date

2016 Year 05 Month 25 Day

Date of closure to data entry

2016 Year 06 Month 11 Day

Date trial data considered complete

2016 Year 06 Month 15 Day

Date analysis concluded

2016 Year 06 Month 30 Day


Other

Other related information

(Study No.2015012)


Management information

Registered date

2016 Year 01 Month 16 Day

Last modified on

2019 Year 08 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023774


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name