UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018391
Receipt number 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 16:18:10

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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 or person

Institute

QOL RD Co.,Ltd.

Institute

Department

Personal name



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

Value
https://center6.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