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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018509
Receipt No. R000021338
Scientific Title Effects of a Food Containing Eucommia Ulmoides Oliver Leaf Extract for Reducing Body Fat
Date of disclosure of the study information 2015/07/31
Last modified on 2016/05/10

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Basic information
Public title Effects of a Food Containing Eucommia Ulmoides Oliver Leaf Extract for Reducing Body Fat
Acronym Effects of a Food Containing Eucommia Ulmoides Oliver Leaf Extract for Reducing Body Fat
Scientific Title Effects of a Food Containing Eucommia Ulmoides Oliver Leaf Extract for Reducing Body Fat
Scientific Title:Acronym Effects of a Food Containing Eucommia Ulmoides Oliver Leaf Extract for Reducing Body Fat
Region
Japan

Condition
Condition N/A (healthy adults or adults with obese tendencies)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examine effects of a food containing eucommia ulmoides oliver leaf extract for reducing body fat for 12 weeks ingestion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]CT scanning (visceral fat)
[2]Weight, body fat percentage, BMI
Key secondary outcomes [1]Blood pressure, pulsation
[2]Abdominal girth, hip girth
[3]Hematologic test
[4]Blood biochemical test
[5]Urine analysis
[6]Questionnaire survey
[7]Subject's diary
[8]Doctor's questions

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 Prevention
Type of intervention
Food
Interventions/Control_1 Oral ingestion of the test products containing eucommia ulmoides oliver leaf extract (6 grains per a day; 12 weeks)
Interventions/Control_2 Oral ingestion of the controlproducts not containing eucommia ulmoides oliver leaf extract (6 grains per a day; 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
40 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria [1]Japanese males and females aged 40-65 years
[2]Individuals who are healthy and are not received treatment of disease
[3]Individuals whose BMI is over 25-30
[4]Individuals whose written informed consent has been obtained
[5]Individuals judged appropriate for the study by the principal
Key exclusion criteria [1]Individuals using medical products
[2]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease
[3]Individuals who are sensitive to test product or other foods, and medical products
[4]Individuals who have a history of hepatitis
[5]Individuals with serious anemia
[6]Individuals whose weight has changed significantly in the past one year
[7]Individuals whose amount of exercise has changed significantly in the past one year
[8]Individuals whose average number of cigarettes for smoking is over 21/day
[9]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day)
[10]Individuals whose life style will change during the test period by
[11]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 month or will ingest those foods during the test period
[12]Individuals who participated in other clinical studies in the past three months
[13]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[14]Individuals who are or are posslibly, or are lactating
[15]Individuals judged inappropriate for the study by the principal
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuko Mori
Organization Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch
Division name Internal Department.
Zip code
Address 1-20-11, Ueno, Taito-ku, Tokyo 110-0005 JAPAN
TEL 03-5816-0711
Email info@tes-h.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyasu Tamura
Organization TES Holdings Co., Ltd
Division name Department of Clinical Trial
Zip code
Address 6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL 03-6801-8480
Homepage URL
Email info@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization Kobayashi Pharmaceutical 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
2015 Year 07 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 07 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 30 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
2015 Year 07 Month 31 Day
Last modified on
2016 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021338

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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