UMIN-CTR Clinical Trial

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

No (subjects with high BMI)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

QOL RD Co.,Ltd.

Institute

Department

Personal name

Organization

Kirin Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Protocol No. H27-0401

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