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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000036011
Receipt No. R000041021
Scientific Title Effects of instant coffee containing high levels of chlorogenic acid on the reduction of abdominal fat area in mildly obese men and women: a randomized, double-blind, parallel group comparison trial
Date of disclosure of the study information 2019/03/01
Last modified on 2019/08/22

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Basic information
Public title Effects of instant coffee containing high levels of chlorogenic acid on the reduction of abdominal fat area in mildly obese men and women: a randomized, double-blind, parallel group comparison trial
Acronym Effects of instant coffee containing high levels of chlorogenic acid on the reduction of abdominal fat area
Scientific Title Effects of instant coffee containing high levels of chlorogenic acid on the reduction of abdominal fat area in mildly obese men and women: a randomized, double-blind, parallel group comparison trial
Scientific Title:Acronym Effects of instant coffee containing high levels of chlorogenic acid on the reduction of abdominal fat area
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present trial aimed to examine the effects of continuous consumption of instant coffee containing high levels of chlorogenic acid on abdominal visceral fat area.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visceral fat area (VFA)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

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 Healthy adults
Key exclusion criteria Allergy to drugs or food; current disease or history of severe disease related to the liver, kidney, heart, lungs, or digestive system; systolic blood pressure <90 mmHg; heavy drinker or smoker; extremely irregular dietary habits; shift workers; late-night shift workers; and/or those who were deemed unfit to participate by the principal investigator.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Masanobu
Middle name
Last name Hibi
Organization Kao Corporation
Division name Biological Science Research
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo,131-8501 , JAPAN
TEL +81-3-5630-7268
Email hibi.masanobu@kao.com

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Watanabe
Organization Kao Corporation
Division name Biological Science Research
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo,131-8501 , JAPAN
TEL +81-3-5630-7268
Homepage URL
Email watanabe.takuya@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Miyawaki Orthopedic Clinic
Address 3-1-6, Ariakechou, Eniwa-city,Hokkaido, Japan
Tel 0123-33-4026
Email s-tomita@ndrcenter.co.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 宮脇整形外科医院 (北海道)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 01 Day

Related information
URL releasing protocol Unpublished due to the protocol including the intellectual property rights
Publication of results Published

Result
URL related to results and publications https://www.mdpi.com/2072-6643/11/7/1617
Number of participants that the trial has enrolled 150
Results
Visceral fat area, total abdominal fat area, body weight, and waist circumference significantly decreased in the active group. 
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
23 participants completed and 23 subjects were incorporated into the analyses
Adverse events
No adverse effect related to the test diets reported
Outcome measures
Visceral fat area 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2013 Year 12 Month 17 Day
Date of IRB
2014 Year 12 Month 20 Day
Anticipated trial start date
2014 Year 01 Month 17 Day
Last follow-up date
2014 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 26 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=R000041021

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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