UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the effect of tea on lipid metabolism, and creation of health foods (ice cream) processed from tea
Title of the study (Brief title)	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	Toshiaki Hanafusa
Organization	Osaka Medical College
Division name	Department of Internal Medicine (1)
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	Hisashi Imbe
Organization	Osaka Medical College
Division name	Department of Internal Medicine (1)
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.mdpi.com/2072-6643/10/7/924/htm
Results
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