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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020594
Receipt No. 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

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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
Institute Wakayama Medical University, Graduate School of Health and Nursing Sciences
Institute
Department

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
URL(English) https://upload.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


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