UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056541 |
|---|---|
| Receipt number | R000059867 |
| Scientific Title | Supplementation with nanoparticles of brown rice germ components Reducing alcohol preference by ingestion of brown rice germ nanoparticles Blinded, randomized, controlled trial (interventional trial) |
| Date of disclosure of the study information | 2024/12/24 |
| Last modified on | 2024/12/23 17:14:37 |
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Basic information
Public title
Supplementation with nanoparticles of brown rice germ components Reducing alcohol preference by ingestion of brown rice germ nanoparticles Blinded, randomized, controlled trial (interventional trial)
Acronym
Testing the Effect of Brown Rice Foodicle Consumption on Reducing Alcohol Preference
Scientific Title
Supplementation with nanoparticles of brown rice germ components Reducing alcohol preference by ingestion of brown rice germ nanoparticles Blinded, randomized, controlled trial (interventional trial)
Scientific Title:Acronym
Testing the Effect of Brown Rice Foodicle Consumption on Reducing Alcohol Preference
Region
| Japan |
Condition
Condition
Persons with a high alcohol preference
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of ingestion of a nanoparticulated supplement of brown rice germ components (Brown Rice Foodicle ) on reducing alcohol preference.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage change in PEth within the intervention period for brown rice foodicle (BF) and placebo supplement (PF)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Verbal explanation of consent will be given to those with high alcohol preference with Alcohol Dependence Screening Test (AUDIT) scores of 8-14 and consent will be obtained. Subjects for whom consent has been obtained will be randomly assigned using the minimization method with Mujinwari (Dolphin Systems Inc.) and asked to take brown rice foodicle for 3 months.
Interventions/Control_2
Verbal explanation of consent will be given to those with high alcohol preference with Alcohol Dependence Screening Test (AUDIT) scores of 8-14 and consent will be obtained. Subjects for whom consent has been obtained will be randomly assigned using the minimization method with Mujinwari (Dolphin Systems Inc.) and asked to take placebo supplement for 3 months.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adults 20 years of age or older who are attending the University of the Ryukyus Hospital and whose written consent has been obtained from the individual and who do not meet the exclusion criteria.
Key exclusion criteria
1. severe renal impairment (eGFR < 30 ml/min/1.73 m2) 2. severe hepatic impairment (AST > 100 IU/L or ALT > 100 IU/L)
2. with serious hepatic disorder (AST > 100 IU/L or ALT > 100 IU/L). 3. with malignant tumor.
Patients with malignant tumors. Patients with a history of malignancy who have been treated for at least 2 years will be included in the study. 4.
4. patients with PEth > 200ng/mL and/or AUDIT score > 15 points and suspected alcohol dependence. 5. patients with PEth < 20ng/mL and/or AUDIT score > 15 points and suspected alcohol dependence.
5. with PEth < 20ng/mL and/or AUDIT score of 8 or less, and whose level of alcohol consumption is less than low risk. 6.
6. who are otherwise deemed inappropriate by the attending physician for the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Masuzaki |
Organization
Graduate School of Medicine, University of the Ryukyus
Division name
Division of Endocrinology, Diabetes and Metabolism, Hematology, Rheumatology, (Second Department of Internal Medicine)
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa, Japan
TEL
098-895-1146
hiroaki@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Tsugumi |
| Middle name | |
| Last name | Uema |
Organization
Graduate School of Medicine, University of the Ryukyus
Division name
Division of Endocrinology, Diabetes and Metabolism, Hematology, Rheumatology
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa, Japan
TEL
098-895-1146
Homepage URL
ma2.ky8.26@gmail.com
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
Okinawa Institute of Science and Technology Promotion Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of the Ryukyus
Address
207 Uehara, Nishihara, Okinawa, Japan
Tel
098-895-3331
krinken@acs.u-ryukyu.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
| 2024 | Year | 12 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 12 | Month | 23 | Day |
Last modified on
| 2024 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059867
