UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trials of the lipid improvement effect of Goishi tea evaluated by index LDL cholesterol
Acronym	Clinical trials of lipid improvement effect of Goishi tea
Scientific Title	Clinical trials of the lipid improvement effect of Goishi tea evaluated by index LDL cholesterol
Scientific Title:Acronym	Clinical trials of lipid improvement effect of Goishi tea
Region	Japan

Condition
Condition	Healthy individual
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the LDL lowering effect of the intake of Goishi tea
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	LDL-CHO
Key secondary outcomes	Height,Weight, Blood pressure, T-CHO,HDL-CHO,TP,T-BIL,UN,CRE,UA,ALT,AST, alpha-GTP,ALP,LD,CK,ChE,AMY,Na, K,Cl,Ca, Fe,Blood sugar,HbA1c,CBC

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	NO
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	The subjects drink 195g (about 195mL) Goishi tea twice a day for 12 weeks.
Interventions/Control_2	The subjects drink 195g (about 195mL) placebo twice a day for 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Healthy adults 2. If you sign a consent document, you will be in 65 years or less, and 20 years of age or older 3. The person who have pointed out that high cholesterol in the past year, and who recommended a diet and exercise therapy 4. If LDL cholesterol value of screening tests is greater than or equal to 120mg / dL
Key exclusion criteria	1. Minors 2. Maternal and lactating women 3. The person who is suffering from some sort of disease 4. The person who drink on a daily basis Goishi tea 5. The person principal investigator has determined that inappropriate
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mitsuhiko Miyamura
Organization	Kochi medical school hospital
Division name	pharmacy
Zip code
Address	185-1, Kohasu, Oko, Nankoku, Kochi, Japan
TEL	088-880-2549
Email	miyamus@kochi-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kohei Jobu
Organization	Kochi medical school hospital
Division name	pharmacy
Zip code
Address	185-1, Kohasu, Oko, Nankoku, Kochi, Japan
TEL	088-880-2549
Homepage URL
Email	jm-kouheij@kochi-u.ac.jp

Sponsor
Institute	Kochi medical school hospital
Institute
Department

Funding Source
Organization	Otoyo yutori farm
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 09 Month 14 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 09 Month 09 Day
Date of IRB	2016 Year 09 Month 08 Day
Anticipated trial start date	2016 Year 09 Month 20 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 03 Month 01 Day
Date analysis concluded	2017 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 09 Month 13 Day
Last modified on	2021 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027631