UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043797 |
|---|---|
| Receipt number | R000049559 |
| Scientific Title | Effect of fermented rice drink containing sake lee on blood cholesterol |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2023/04/05 10:07:45 |
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Basic information
Public title
Effect of fermented rice drink containing sake lee on blood cholesterol
Acronym
Effect of fermented rice drink containing sake lee on blood cholesterol
Scientific Title
Effect of fermented rice drink containing sake lee on blood cholesterol
Scientific Title:Acronym
Effect of fermented rice drink containing sake lee on blood cholesterol
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of fermented rice drink containing sake lee on serum LDL-cholesterol level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
12-week changes in serum LDL-cholesterol
Key secondary outcomes
12-week changes in BMI, body fat percentage, abdominal circumference, blood glucose, T-Cho, HDL-Cho, TG, ALT, AST, r-GTP, and fecal bile acid concentration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of fermented rice drink containing sake lee (190 g/day) for 12 weeks.
Interventions/Control_2
Intake of placebo drink (without fermented rice and sake lee) (190 g/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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
120<=LDL-Cho<159
Key exclusion criteria
1) Allergy to fermented rice drink or sake lee
2) In pregnancy or nursing a child
3) Taking medicines or receiving health guidance for hypertension, diabetes, and/or hyperlipidemia
4) Taking drugs or functional food that may affect the body fat percentage and serum cholesterol
5) Taking large volume of fermented rice drink or sake lee habitually
6) Participation in any clinical trial within 90 days of the commencement of the trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Noda |
Organization
Graduate School of Biomedical and Health Sciences
Hiroshima University
Division name
Probiotic Science for Preventive Medicine
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5288
bel@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Noda |
Organization
Graduate School of Biomedical and Health Sciences Hiroshima University
Division name
Probiotic Science for Preventive Medicine
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5288
Homepage URL
bel@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-ku, Hiroshima 734-8551
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.ac.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
| 2021 | Year | 03 | Month | 31 | 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
40
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
| 2021 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 08 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
40 participants were already entered.
The data obtained from the present study are now analyzing.
Management information
Registered date
| 2021 | Year | 03 | Month | 31 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049559
| Research Plan | |
|---|---|
| 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 |
