UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of effects of food containing hop extract on reducing body fat.
Title of the study (Brief title)	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	Kazuhiko Fujisawa
Organization	Ageokousei Hospital
Division name	Director
Address	421-1 ,Jitogata, Ageo-shi, Saitama,Japan
TEL	048-781-1101
Email	masayuki.nakamura@achs.jp

Public contact
Name of contact person	Chiaki Shibakiri
Organization	QOL RD Co.,Ltd.
Division name	CRO Department Food Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021297