UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037835 |
|---|---|
| Receipt number | R000043137 |
| Scientific Title | The effect of HBF2019-02 on lipid metabolism |
| Date of disclosure of the study information | 2019/09/16 |
| Last modified on | 2020/12/17 15:23:24 |
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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
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
chiyo.yoshizane@hb.nagase.co.jp
Sponsor or person
Institute
Oneness Support Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043137
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
