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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028062
Receipt No. R000031836
Scientific Title Study on effects of long-tern ingestion of fermented tea leaf powder "Marugoto Hakkocha" made from green tea leaves and loquat leaves on body fat.
Date of disclosure of the study information 2017/07/07
Last modified on 2018/01/05

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Basic information
Public title Study on effects of long-tern ingestion of fermented tea leaf powder "Marugoto Hakkocha" made from green tea leaves and loquat leaves on body fat.
Acronym Effects of fermented tea leaf powder on body fat.
Scientific Title Study on effects of long-tern ingestion of fermented tea leaf powder "Marugoto Hakkocha" made from green tea leaves and loquat leaves on body fat.
Scientific Title:Acronym Effects of fermented tea leaf powder on body fat.
Region
Japan

Condition
Condition obesity
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of long-tern ingestion fermented tea leaf powder on suppression of body fat.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visceral fat area
Key secondary outcomes Body weight,Body fat percentage,BMI,Waist length,Blood pressure,Serum cholesterol,Serum triglyceride,Blood glucose level,GOT,GPT,Gamma-GTP,White blood cell count,Red blood cell count,hemoglobin,Hematocrit,Platelet count,LD,Total Bilirubin,ALP,HbA1c,Total protein,Albumin,Urea nitrogen,Creatinine,uric acid,questionnaire

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 The subjects ingested the active meal for eight weeks.
Interventions/Control_2 The subjects ingested the placebo meal for eight 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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) Healthy male and female aged 20 to 70
2) Individuals whose visceral fat area is approximately 60 cm2 or more and BMI is 23 to 30
3) Individuals who can refrain from drinking and eating during the test period
4) Individuals who understand the purpose and contents of the experiment
Key exclusion criteria 1)Individuals taking drugs, supplements and healthy foods which affect the lipid metabolism.
2)Subjects who are contracting diabetes,kidney and/or liver diseases.
3)Individuals who have been diagnosed with familial hyperlipemia.
4)Individuals with a chronic diseases.
5)Individuals who can not stop taking a large amount of green tea or black tea during the examination period
6)Pregnant women,or women with intending to become pregnant,and lactating woman.
7)Individuals participating or intending to participate in a drug administration test.
8)Individuals judged by the doctor to be unsuitable.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunari Tanaka
Organization Univercity of Nagasaki
Division name Faculty of Nursing and Nutrition
Zip code
Address 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL 095-813-5216
Email katanaka@sun.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Ito
Organization Univercity of Nagasaki
Division name Faculty of Nursing and Nutrition
Zip code
Address 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL 095-813-5500
Homepage URL
Email katanaka@sun.ac.jp

Sponsor
Institute Univercity of Nagasaki
Institute
Department

Funding Source
Organization charle 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
2017 Year 07 Month 07 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 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 12 Month 16 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 04 Day
Last modified on
2018 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031836

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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