UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048588 |
|---|---|
| Receipt number | R000055145 |
| Scientific Title | Effect of intake of a food containing rice bran fermented product on reducing LDL cholesterol. |
| Date of disclosure of the study information | 2022/08/20 |
| Last modified on | 2023/01/24 11:25:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of intake of a food containing rice bran fermented product on reducing LDL cholesterol.
Acronym
Effect of intake of a food containing rice bran fermented product on reducing LDL cholesterol.
Scientific Title
Effect of intake of a food containing rice bran fermented product on reducing LDL cholesterol.
Scientific Title:Acronym
Effect of intake of a food containing rice bran fermented product on reducing LDL cholesterol.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effect of intake of a food containing rice bran fermented product on reducing LDL cholesterol.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LDL cholesterol (Week 0, Week 6 and Week 12).
Key secondary outcomes
*Secondary outcomes
[1] Indexes for lipid metabolism(1)
[2] Quality of life related research using Fitbit(2)
[3] Dietary survey with Brief-type Self-Administered Diet History Questionnaire (BDHQ)(1)
[4] Questionnaire survey on QOL(1)
*Safety
[1] Blood pressure, pulsation (1)
[2] Weight, body fat percentage, BMI (1)
[3] Hematologic test (1)
[4] Blood biochemical test (1)
[5] Urine analysis (1)
[6] Subject's diary (2)
[7] Doctor's questions (1)
[8] Adverse events: number of cases and expression rate of adverse events (3)
(1): Week 0, Week 6 and Week 12
(2): Daily for Week 0 to Week 12
(3): Week 6 and Week 12
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
Oral intake of test food (Once a day; 12 weeks).
Interventions/Control_2
Oral intake of placebo food (Once a day; 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 Japanese males and females aged 20-64 years.
[2]Subjects who are healthy and have no chronic physical disease.
[3]Subjects with LDL cholesterol in the range 120-139 mg/dL.
[4]Subjects whose written informed consent has been obtained after explanation of this study.
[5]Subjects who can have an examination on a designated check day.
[6]Subjects who are judged appropriate for the study by the principal.
Key exclusion criteria
[1]Subjects using medicines
[2]Subjects who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia
[3]Subjects who have a history of disease of liver, kidney, heart, lung, and blood
[4]Subjects having digestive disease
[5]Subjects who fall any criteria when using Fitbit
[6]Subjects having drugs within 3 months
[7]Subjects having allergies to foods and medicines
[8]Subjects whose BMI is over 30 kg/m2
[9]Subjects who donated blood over 200 mL in the past 1 month or over 400 mL in the past 3 months
[10]Subjects who continuously intake of functional foods, health foods, supplements, and beverages
[11]Heavy drinker (over 40 g/day)
[12]Subjects who cannot use application or smartphone for administrating the data of Fitbit
[13]Subjects who cannot always ware Fitbit
[14]Subjects with changing lifestyle
[15]Shift worker or night worker
[16]Pregnant, possible pregnant, or lactating
[17]Subjects who participated in the other clinical studies in the past 3 months.
[18]Subjects who work for a company that commodify health and functional foods by the subjects or his family
[19]Subjects who are judged inappropriate for the study by the principal.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinc
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.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
| 2022 | Year | 08 | Month | 20 | 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
| 2022 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 04 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055145
