UMIN-CTR Clinical Trial

Basic information
Public title	The effect of HBF2019-02 on lipid metabolism
Acronym	The effect of HBF2019-02 on lipid metabolism
Scientific Title	The effect of HBF2019-02 on lipid metabolism
Scientific Title:Acronym	The effect of HBF2019-02 on lipid metabolism
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of HBF2019-02 on lipid metabolism
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Lipid metabolism related indicators
Key secondary outcomes	Physical examination, and medical examination by hematology, blood biochemistry, urinalysis

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of test food for 12 weeks
Interventions/Control_2	Ingestion of placebo food 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
Key inclusion criteria	(1) Healthy adult men (2) LDL-Cho from 120 to 139 mg / dL or LDL-Cho from 140 to 159 mg / dL (3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	(1) Subjects with hepatic, renal, cardiac and/or organ disorders, diabetes, and/or other serious diseases. (2) Subjects with abnormal liver and kidney function test values. (3) Subjects with a disease currently being treated. (4) Subjects with food and drug allergies. (5) Subjects with anemia. (6) Subjects who play intense sports and subjects who are on a diet. (7) Subjects who cannot refrain from taking health foods (including certain health foods and functionally labeled foods) and designated quasi drugs during the test period. (8) Those who continue to take medicines (including OTC and prescription drugs). (9) Those who consume excessive alcohol, or who cannot ban alcohol from the day before the test to the day. (10) Participants in or planning to participate in other clinical studies at the start of this study. (11) Subjects who judged as unsuitable for this study by the principal investigator for any reasons.
Target sample size	22

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal Medicine
Zip code	530-0044
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-6135-5200
Email	info@miula-cl.jp

Public contact
Name of contact person	1st name Chiyo Middle name Last name Yoshizane
Organization	Hayashibara CO., LTD.
Division name	R&D Division, Development Unit
Zip code	702-8006
Address	675-1, Fujisaki, Naka-ku, Okayama
TEL	086-276-3141
Homepage URL
Email	chiyo.yoshizane@hb.nagase.co.jp

Sponsor
Institute	Oneness Support Co., Ltd
Institute
Department

Funding Source
Organization	Hayashibara CO., LTD
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	The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel	06-6135-5200
Email	mterashima@miura-cl.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	医療法人花音会みうらクリニック（大阪府） / Miura Clinic, Medical Corporation Kanonkai (Osaka)

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 16 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	2019 Year 08 Month 22 Day
Date of IRB	2019 Year 08 Month 22 Day
Anticipated trial start date	2019 Year 09 Month 17 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 28 Day
Last modified on	2020 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043137