UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011901 |
|---|---|
| Receipt number | R000013903 |
| Scientific Title | Study of the effect of tea on lipid metabolism, and creation of health foods processed from tea |
| Date of disclosure of the study information | 2013/09/29 |
| Last modified on | 2016/05/26 14:23:00 |
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Basic information
Public title
Study of the effect of tea on lipid
metabolism, and creation of health foods processed from tea
Acronym
Study of the effect of tea on lipid
metabolism, and creation of health foods processed from tea
Scientific Title
Study of the effect of tea on lipid
metabolism, and creation of health foods processed from tea
Scientific Title:Acronym
Study of the effect of tea on lipid
metabolism, and creation of health foods 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
6) proinflammatory cytokine
7) AST, ALT, gamma-GTP
8) Serum iron, ferritin
9) adiponectin
10) urinalysis
11) diet survey
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 barley tea extracts powder
dissolved in 200 ml of water three times
a day (total of 600 ml, the amount of
catechins and O-methylated EGCG are 0
mg and 0 mg, respectively) for 12 weeks.
Interventions/Control_2
Take 3 g of Yabukita green tea extracts
powder dissolved in 200 ml of water three
times a day (total of 600 ml, the amount
of catechins and O-methylated EGCG
are 600 mg and 0 mg, respectively) for 12
weeks.
Interventions/Control_3
Take 3 g of Benifuuki green tea extracts
powder dissolved in 200 ml of water three
times a day (total of 600 ml, the amount
of catechins and O-methylated EGCG
are 600 mg and 40 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 more
2.Body mass index: 25kg/m^2 or more
Key exclusion criteria
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 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
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
in1297@poh.osaka-med.ac.jp
Sponsor or person
Institute
Department of Internal Medicine(1),Osaka
Medical College
Institute
Department
Personal name
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
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
| 2013 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S1756464616301189
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
| 2013 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 10 | Month | 29 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 28 | Day |
Last modified on
| 2016 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013903
