UMIN-CTR Clinical Trial

Basic information
Public title	Effects of burdock sprout extract on decreasing LDL-cholesterol level; A single center double blind randomized controlled trial
Acronym	Study for effects of burdock sprout extract on decreasing LDL-cholesterol level
Scientific Title	Effects of burdock sprout extract on decreasing LDL-cholesterol level; A single center double blind randomized controlled trial
Scientific Title:Acronym	Study for effects of burdock sprout extract on decreasing LDL-cholesterol level
Region	Japan

Condition
Condition	abnormal lipid metabolism
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate effects of burdock sprout extract on decreasing LDL-cholesterol level and other factors such as triglyceride in the patients whose LDL-cholesterol level is higher than normal range even after nutritional guidance.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Decrease in LDL-cholesterol level in the patients whose LDL-cholesterol level is higher than normal range at 12 weeks after taking burdock sprout extract.
Key secondary outcomes	Change of liver function, other kinds of serum lipid level, blood glucose level, and other cytokine and adipokine levels such as leptin and tumor necrosis factor-alpha in the patients whose LDL-cholesterol level is higher than normal range at 4 and 12 weeks after taking burdock sprout extract, and Fib-4 index

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	burdock sprout extract (+)
Interventions/Control_2	burdock sprout extract (-)
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. A patient whose total cholesterol level is over 230 mg/dL, or LDL-colesterol level is over140mg/dL 2. A patient who attended nutritional guidance 4 weeks or more before starting this study
Key exclusion criteria	1. A patient who is taking any drugs affecting lipid metabolism 2. A patient who cannot stop any supplements health food affecting lipid metabolism 3. A patient who is pregnant, or may become pregnant, or desire to get pregnant 4. A patient who has or had serious diseases in heart, liver, kidney, gastrointestinal tract, etc. 5. A patient who has allergy for any drugs or food 6. A patient who has or had drug or alcohol dependence 7. A patient who is judged to be unsuitable for this study by the doctor
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yoshinori Middle name Last name Horie
Organization	Shonan Keiiku Hospital
Division name	Internal Medicine
Zip code	252-0816
Address	4360 Endo Fujisawa-shi Kanagawa-ken, 252-0816, Japan
TEL	0466-48-0050
Email	y-horie@keiiku.gr.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Miyazaki
Organization	Shonan Keiiku Hospital
Division name	Office
Zip code	252-0816
Address	4360 Endo Fujisawa-shi Kanagawa-ken, 252-0816, Japan
TEL	0466-48-0050
Homepage URL
Email	k-miyazaki@keiiku.gr.jp

Sponsor
Institute	Shonan Keiiku Hospital
Institute
Department

Funding Source
Organization	Kracie Holdings Co. Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Keio University, Graduate School of Media and Governance
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shonan Keiiku Hospital
Address	4360 Endo Fujisawa-shi Kanagawa-ken, 252-0816, Japan
Tel	0466-48-0050
Email	k-miyazaki@keiiku.gr.jp

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	2018 Year 12 Month 01 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	2018 Year 11 Month 08 Day
Date of IRB	2018 Year 11 Month 04 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2021 Year 07 Month 01 Day
Date of closure to data entry	2021 Year 09 Month 01 Day
Date trial data considered complete	2021 Year 09 Month 01 Day
Date analysis concluded	2021 Year 09 Month 27 Day

Other
Other related information

Management information
Registered date	2018 Year 11 Month 09 Day
Last modified on	2021 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039719