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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018391
Receipt No. R000021297
Scientific Title Study of effects of food containing hop extract on reducing body fat.
Date of disclosure of the study information 2017/03/31
Last modified on 2016/08/19

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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 Weight, BMI, Body fat percentage, Waist circumference, Hip circumference, A ratio of waist circumference and hip circumference.

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, single daily feeding for 12 weeks.
Interventions/Control_2 Placebo food not containing hop extract, single daily feeding 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 who are the age of 20 to less than the age of 65 years old.
(2)Subjects with BMI 25-35kg/m2.
(3)Subjects giving written informed consent.
Key exclusion criteria (1)Subjects who are on a diet.
(2)Subjects who have a history of serious disease (e.g., liver disease, kidney disease, heart disease, lung disease, digestive disease, diabetes, organopathy, and/or food allergy, thyroid gland disease, adrenal gland disease, and/or metabolic disorder).
(3)Subjects who are under treatment.
(4)Subjects who have under treatment or a history of drug addiction and/or alcoholism.
(5)Subjects who have drug allergy, food allergy, and/or possibility of allergy symptoms onset.
(6)Subjects who have subjective symptoms of anemia.
(7)Subjects who use oral medication or supplement affecting body fat and/or lipid metabolism.
(8)Subjects with excessive alcohol-drinking behaviors (over 20 g pure alcohol/day).
(9)Subjects who use foods containing ingredients derived from hop constantly.
(10)Subjects who are shift workers or graveyard shift workers.
(11)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(12)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.
(13)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.
(14)Subjects who are planned to have barium test during the study period.
(15)Subjects who can't visit the hospital on the inspection date.
(16)Subjects who are embedded metals in the abdominal region.
(17)Subjects who work for Health Food Company.
(18)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 Kazuhiko Fujisawa
Organization Ageokousei Hospital
Division name Director
Zip code
Address 421-1 ,Jitogata, Ageo-shi, Saitama,Japan
TEL 048-781-1101
Email masayuki.nakamura@achs.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chiaki Shibakiri
Organization QOL RD Co.,Ltd.
Division name CRO Department Food Division
Zip code
Address 2-14-1,Nihonbashi,Chuo-Ku,Tokyo,Japan
TEL 03-6386-8809
Homepage URL
Email c-shibakiri@qol-rd.co.jp

Sponsor
Institute QOL RD Co.,Ltd.
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
2017 Year 03 Month 31 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
2015 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 24 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. H27-0401

Management information
Registered date
2015 Year 07 Month 23 Day
Last modified on
2016 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021297

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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