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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000014185
Receipt No. R000016518
Scientific Title Study of effects of food containing hop extract on reducing body fat.
Date of disclosure of the study information 2014/06/06
Last modified on 2015/07/02

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Basic information
Public title Study of effects of food containing hop extract on reducing body fat.
Acronym Effects of food containing hop extract on reducing body fat.
Scientific Title Study of effects of food containing hop extract on reducing body fat.
Scientific Title:Acronym Effects of food containing hop extract on reducing body fat.
Region
Japan

Condition
Condition No (subjects with high BMI)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effects of food containing hop extract on reducing body fat.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Abdominal fat area
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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 Food containing hop extract, 1 food per day for 12 weeks.
Interventions/Control_2 Placebo food not containing hop extract, 1 food per day 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 (1)(Healthy) subjects aged greater than 20 and less than 65 years old.
(2)Subjects with BMI greater than 25 and less than 30 kg/m^2.
(3)Subjects giving written informed consent.
Key exclusion criteria (1)Subjects who are on a diet.
(2)Subjects who use oral medication affecting body fat and/or lipid metabolism.
(3)Subjects who constantly use supplements and/or functional foods affecting body fat and/or lipid metabolism.
(4)Subjects who use foods containing ingredients derived from hops constantly.
(5)Subjects with excessive alcohol-drinking behaviors.
(6)Subjects who are under treatment.
(7)Subjects who has possibility of allergy symptoms onset.
(8)Subjects who have a history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
(9)Subjects who have severe anemia.
(10)Subjects who have a history of digestive disease affecting digestion and absorption.
(11)Subjects who have under treatment or a history of drug addiction and/or alcoholism.
(12)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(13)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(14)Subjects who are judged as unsuitable for the study based on the results of blood test.
(15)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study.
(16)Subjects who have donated over 200 mL of blood and/or blood component within the last one month prior to the current study or over 400 mL of blood and/or blood component within the last three months prior to the current study.
(17)Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name (1)Yasuyuki Kowatari (2)Sumio Kondo
Organization (1)Ueno Clinic
(2)Fukushima Healthcare Center
Division name (1)Internal Medicine (2)Internal Medicine
Zip code
Address (1)2-18-6 Higashiueno, Taito-ku, Tokyo (2)2-12-16 Tamakawa, Fukusima-ku, Osaka-shi, Osaka
TEL (1)03-3834-3518(2)06-6441-6848
Email kowatari@04.alumni.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Muneaki Iizuka
Organization Total Technological Consultant Co., Ltd. (TTC)
Division name Clinical Research Planning Dept.
Zip code
Address 1-20-2 Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email m.iizuka@ttc-tokyo.co.jp

Sponsor
Institute Total Technological Consultant Co., Ltd. (TTC)
Institute
Department

Funding Source
Organization Kirin Co., Ltd.
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
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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 06 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 Completed
Date of protocol fixation
2014 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Protocol No. 26920

Management information
Registered date
2014 Year 06 Month 06 Day
Last modified on
2015 Year 07 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016518

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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