UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036011
Receipt number 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 15:51:52

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Kao Corporation

Institute

Department

Personal name



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

Value
https://center6.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