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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028706
Receipt No. 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

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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
Institute KSO Corporation
Institute
Department

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
URL(English) https://upload.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


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