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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033084
Receipt No. R000037726
Scientific Title An investigation on the visceral fat reduction effect and the safety of coffee.
Date of disclosure of the study information 2018/06/21
Last modified on 2018/12/26

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Basic information
Public title An investigation on the visceral fat reduction effect and the safety of coffee.
Acronym An investigation on the visceral fat reduction effect and the safety of coffee.
Scientific Title An investigation on the visceral fat reduction effect and the safety of coffee.
Scientific Title:Acronym An investigation on the visceral fat reduction effect and the safety of coffee.
Region
Japan

Condition
Condition N/A(People with a BMI of at least 25 kg/m2 and less than 30kg/m2.)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the visceral fat reduction effect and the safety of continuous consumption of coffee for a period of 12 weeks, using adult men and women with a BMI of at least 25 kg/m2 and less than 30kg/m2.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Visceral Fat
Measured at initial, 4 week, 8 week, and 12 week visits
Key secondary outcomes Weight
Measured at initial, 4 week, 8 week, and 12 week visits

BMI
Measured at initial, 4 week, 8 week, and 12 week visits

Waist Circumference
Measured at initial, 4 week, 8 week, and 12 week visits


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 Treatment
Type of intervention
Food
Interventions/Control_1 Placebo (30 patients)
Coffee.
Consumption period of 12 weeks. 1 drink per day.
Interventions/Control_2 Intervention (30 patients)
Coffee.
Consumption period of 12 weeks. 1 drink per day.
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 1. Adults (men and women) who are at least 20 and under 65 years of age when Informed Consent is taken
2. People with a BMI of at least 25 kg/m2 and less than 30 kg/m2
3. People who voluntary give written informed consent to participate in the study before study begins
Key exclusion criteria 1. People who have very irregular dietary habits
2. People on continuous treatment with medication
3. People with medicine or food allergies
4. People using medicine, foods for specified health uses, foods with functional claims, supplements, or diet products that may have an effect on the study
5. People with hypertension , diabetes mellitus, dyslipidemia ,or other lifestyle-related diseases
6. People with gastrointestinal dysfunction, significant liver dysfunction, significant kidney dysfunction, or significant cardiovascular disease
7. People with a history of a gastrectomy/extensive digestive tract excision
8. People with dependence on drugs or alcohol
9. People who are pregnant, nursing, or plan to become pregnant
10. Other people determined to be unsuitable for participation in the study by the principal investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuguyoshi Asano
Organization Asano Kanamachi Clinic
Division name Director
Zip code
Address 1-18-3, Higashikanamachi, Katsushika-ku, Tokyo, Japan Postal Code: 125-0041
TEL 03-3609-7511
Email dr-asano@syd.odn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Research Support Center
Organization Increase Co., Ltd.
Division name Clinical Development Department
Zip code
Address 1-5-6, Nihonbashi Bakuro-cho, Chuo-ku, Tokyo Imasu Office Bakurocho Bldg 8F Postal Code: 103-0002
TEL 03-6231-1394
Homepage URL
Email key001@inc-cro.co.jp

Sponsor
Institute Tsuguyoshi Asano
Institute
Department

Funding Source
Organization Key Coffee Inc.
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
Address
Tel
Email

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 あさの金町クリニック(東京都)、ふたばクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 21 Day
Last modified on
2018 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037726

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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