UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028706
Receipt number R000032862
Scientific Title Validation study of food containing BARLEYmax on reducing body fat: Randomized double blind placebo control studies
Date of disclosure of the study information 2017/08/17
Last modified on 2018/08/24 18:27:41

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Basic information

Public title

Validation study of food containing BARLEYmax on reducing body fat: Randomized double blind placebo control studies

Acronym

Validation study for reducing body fat by BARLEYmax

Scientific Title

Validation study of food containing BARLEYmax on reducing body fat: Randomized double blind placebo control studies

Scientific Title:Acronym

Validation study for reducing body fat by BARLEYmax

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine effects of BARLEYmax on reducing body fat

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Abdominal visceral fat area, abdominal subcutaneous fat area, and abdominal total fat area, at 12weeks after intake

Key secondary outcomes

Body weight(BMI), abdominal circumherence, fasting blood sugar level and serum lipids(total cholesterol, LDL-cholesterol, Triglycerides), at 6 and 12weeks after intake
Measurement of intestinal flora and adiponectin(polymer), at 12weeks
Defecation frequency and stool output


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

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

Granola containing BARLEYmax, 1 food per day for 12 weeks

Interventions/Control_2

Granola not containing BARLEYmax, 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

30 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

1.Males and females aged greater than 30 and less than 60 years old
2.Subjects who usually have 3 balanced meals a day except persons who eat fermented soybeans or granola everyday
3.Subjects with BMI greater than 23 and less than 30 kg/m^2 except persons under treatment of obesity
4.Subjects who usually drink alcohol once or twice a week at most
5.Subjets giving written informed consent

Key exclusion criteria

1.Subjects who takes oral medication affecting obesity, hyperlipidemia and lipid metabolism
2.Subjects who suffer a severe illness in liver, cardiovascular, respiratory, endocrine, metabolism and allergy
3.Subjects who are not able to stop to take in food or supplement affecting obesity, hyperlipidemia and lipid metabolism
4.Subjects who have under treatment or a history of drug addiction and/or alcoholism
5.Subjects who have a metal component in the abdomen
6.Subjects who have a cardiac pacemaker
7.Subjects who have food allergy
8.Subjects who were diagnosed as familial hyperlipidemia
9.Pregnant and lactating female, or who wish to get pregnant during the study period
10. Subjects who is already participating or participated within 1 month in other clinical trials, subjects planning to participate during this examination period
11.Subjects who are ineligible due to physician's judgment

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinori Seko

Organization

Motoyawata Central Internal medicine Clinic

Division name

Director

Zip code


Address

3-3-3 Yawata, Ichikawa, Chiba, Japan

TEL

047-704-9922

Email

motoyawata-cmc@wd6.so-net.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eiji Yoshikawa

Organization

KSO Corporation

Division name

Sales department

Zip code


Address

1-9-7, Shibaura, Minato-ku, Tokyo, Japan

TEL

03-3452-7733

Homepage URL


Email

yoshikawa@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

TEIJIN LIMITED

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 08 Month 17 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

2017 Year 08 Month 04 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 07 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 17 Day

Last modified on

2018 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032862


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name