UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014185
Receipt number 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 18:25:02

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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 or person

Institute

Total Technological Consultant Co., Ltd. (TTC)

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

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

Value
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