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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015009
Receipt No. R000017351
Scientific Title Study of the effect of tea on lipid metabolism, and creation of health foods (ice cream) processed from tea
Date of disclosure of the study information 2014/09/01
Last modified on 2018/07/19

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Basic information
Public title Study of the effect of tea on lipid
metabolism, and creation of health foods (ice cream) processed from tea
Acronym Study of the effect of tea on lipid
metabolism, and creation of health foods (ice cream) processed from tea
Scientific Title Study of the effect of tea on lipid
metabolism, and creation of health foods (ice cream) processed from tea
Scientific Title:Acronym Study of the effect of tea on lipid
metabolism, and creation of health foods (ice cream) processed from tea
Region
Japan

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

Objectives
Narrative objectives1 To assess the effects of adding O-Methylated
EGCG to EGCG on biomarkers of lifestyle-related diseases in subjects prone to dyslipidemia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) LDL-cholesterol
2) Total cholesterol
Key secondary outcomes 1) body weight, waist, blood pressure
2) Serum total cholesterol, MDA-LDL,
triglycerides
3) FPG, HbA1c, glycated albumin, insulin
4) high sensitive C reactive protein, catechin sensing molecule
5) antioxidant action in vivo, metabolite
6) proinflammatory cytokine
7) AST, ALT, gamma-GTP
8) Serum iron, ferritin
9) adiponectin
10) urinalysis
11) diet survey
12) stool examinationstool examination (intestinal flora, enterobacterial genes involved in metabolism)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Take 3 g of Benifuuki green tea extracts
powder dissolved in 125 ml of ice cream once a day (the amount of catechins and O-methylated EGCG are 600 mg and 40 mg, respectively) for 12 weeks.
Interventions/Control_2 Take 1.5 g of Benifuuki green tea extracts
powder dissolved in 125 ml of ice cream once a day (the amount of catechins and O-methylated EGCG are 300 mg and 20 mg, respectively) for 12 weeks.
Interventions/Control_3 Take 0 g of Benifuuki green tea extracts
powder dissolved in 125 ml of ice cream once a day (the amount of catechins and O-methylated EGCG are 0 mg and 0 mg, respectively) for 12 weeks.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria From 20 years old to 80 years old and meets
the followings;
1.LDL-Cholesterol: 120mg/dl or higher
2.Body mass index: 18.5kg/m^2 or higher
Key exclusion criteria 0) HbA1c: less than 6.5%
1) Individuals with a medical record of heart failure or cardiac infarction.
2) Individuals judged to have atrial fibrillation,
irregular Heart Beat, hepatic damage, kidney damage, cerebrovascular accident,
rheumatism, diabetes mellitus, lipid disorder and/or anemia.
3) Individuals with a medical record of severe allergy to food and drug.
4) Pregnant women, or women with intending
to become pregnant, and lactating women.
5) Individuals judged by the doctor to be
unsuitable.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Hanafusa
Organization Osaka Medical College
Division name Department of Internal Medicine (1)
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka
TEL 072-683-1221
Email hanafusa@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Imbe
Organization Osaka Medical College
Division name Department of Internal Medicine (1)
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka
TEL 072-683-1221
Homepage URL
Email in1297@poh.osaka-med.ac.jp

Sponsor
Institute Department of Internal Medicine(1),Osaka
Medical College
Institute
Department

Funding Source
Organization National Agriculture and Food Research
Organization
Organization
Division
Category of Funding 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
2014 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.mdpi.com/2072-6643/10/7/924/htm
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
2014 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 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
2014 Year 09 Month 01 Day
Last modified on
2018 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017351

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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