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 |
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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
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
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
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
