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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025076
Receipt No. R000028777
Scientific Title Effects of a Drink Containing Citrus Fruit Juice for Reducing Body Fat
Date of disclosure of the study information 2016/11/30
Last modified on 2017/03/12

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Basic information
Public title Effects of a Drink Containing Citrus Fruit Juice for Reducing Body Fat
Acronym Effects of a Drink Containing Citrus Fruit Juice for Reducing Body Fat
Scientific Title Effects of a Drink Containing Citrus Fruit Juice for Reducing Body Fat
Scientific Title:Acronym Effects of a Drink Containing Citrus Fruit Juice for Reducing Body Fat
Region
Japan

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

Objectives
Narrative objectives1 This study examines effects of a drink containing citrus fruit juice for reducing body fat
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Abdominal visceral fat mass (Week 0, Week 8, Week 12)
Key secondary outcomes *Secondary outcomes
[1]Weight, body fat percentage, BMI (Week 0, Week 8, Week 12)
[2]Abdominal girth (Week 0, Week 8, Week 12)
[3]Blood test (adiponectin) (Week 0, Week 8, Week 12)
[4]Questionnaire survey (Week 0, Week 8, Week 12)

*Safety
[1]Blood pressure, pulsation (Week 0, Week 8, Week 12)
[2]Hematologic test (Week 0, Week 8, Week 12)
[3]Blood biochemical test (Week 0, Week 8, Week 12)
[4]Urine analysis (Week 0, Week 8, Week 12)
[5]Doctor's questions (Week 0, Week 8, Week 12)

*Other outcomes
[1]Dietary survey (3 days prior to each inspection date)
[2]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

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 Oral intake of the test drink (200mL in a day; 12 weeks)
Interventions/Control_2 Oral intake of the placebo drink (200mL in 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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria [1]Males and Females aged 20-74 years
[2]Individuals whose BMI is 23-29
[3]Individuals whose written informed consent has been obtained
[4]Individuals who can have an examination in a designated day
[5]Individuals judged appropriate for the study by the principal
Key exclusion criteria [1]Individuals who are visceral fat type obesity defined in Guidelines for the Management of Obesity Disease.
[2]Individuals using medical products.
[3]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[4]Individuals who used or applied a drug for treatment of disease in the past 1 month.
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[6]Individuals who are a patient or have a history of or endocrine disease.
[7]Individuals whose BMI is over 30.
[8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[9]Individuals with serious anemia.
[10]Individuals who are sensitive to test product or other foods, and medical products.
[11]Individuals having a habit to intake foods containing components which are contained in the test product.
[12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[13]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[14]Individuals having a habit to intake a drink containing citrus juice.
[15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements containing hesperidin and nobiletin in the past 3 months or will ingest those foods during the test period.
[16]Individuals who have a habit to use drug claiming to reduce body fat in the past 3 months.
[17]Individuals who participated in other clinical studies in the past 3 months.
[18]Individuals judged inappropriate for the study by the principal.
Target sample size 48

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 Head of center
Zip code
Address 1-20-11, Ueno, Taito-ku, Tokyo 110-0005 JAPAN
TEL +81-3-5816-0711
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 Development for Clinical Trials
Zip code
Address 6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL +81-3-6801-8480
Homepage URL
Email t.tamura@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization Okinawa TLO 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
2016 Year 11 Month 30 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
2016 Year 11 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 03 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
2016 Year 11 Month 30 Day
Last modified on
2017 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028777

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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