UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053495 |
|---|---|
| Receipt number | R000061053 |
| Scientific Title | Evaluation of health function of cooked rice with emulsified formulation: Single-arm open study |
| Date of disclosure of the study information | 2024/02/03 |
| Last modified on | 2024/07/31 09:16:32 |
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Basic information
Public title
Evaluation of health function of cooked rice with emulsified formulation: Single-arm open study
Acronym
Evaluation of health function of cooked rice with emulsified formulation: Single-arm open study
Scientific Title
Evaluation of health function of cooked rice with emulsified formulation: Single-arm open study
Scientific Title:Acronym
Evaluation of health function of cooked rice with emulsified formulation: Single-arm open study
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Accessing the glycemic response to the rice with emulsified formulation including rice bran oil
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose and insulin levels
Key secondary outcomes
Blood triglyceride level, Blood total GLP-1 and GIP levels, Anthropometric tests, blood biochemical tests, and hematologic tests
<Exploratory outcomes>
Brief-type self-administrated diet history questionnaire (BDHQ), Eating behavior questionnaire Continuous glucose monitor, Sensory questionnaire, Body Composition analysis by DEXA method
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Placebo food (a single time intake) > 2-week washout > Treatment food (a single time intake)
Interventions/Control_2
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
Key inclusion criteria
(1) Healthy male subjects aged from 20 to 75 years old
(2) Subjects who voluntary participate in the clinical trial and provide consent form
(3) Subjects who can maintain a consent daily lifestyle during the study period
(4) 15 subjects with normal high blood glucose or large daily blood glucose fluctuations determined by venous blood collection analysis data after eating 200 g of cooked rice and continuous glucose monitor data
(5) Subjects who are approved to participate by the medical doctor
Key exclusion criteria
(1) Subjects who suffer from serious diseases (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental disorders
(2) Subjects with a history of serious diseases (diabetes, heart disease, liver disease, renal disease, cancer, etc.) in the past
(3) Subjects who donated more than 200 mL of blood in the past month or more than 400 mL of blood within 3 months.
(4) Subjects who have experienced poor mood or deterioration of physical condition due to blood collection in the past, or have been told that blood collection is difficult due to narrow blood vessels.
(5) Subjects who have severe anemia symptoms
(6) Subjects who are unable to maintain their daily lifestyle due to significant changes in diet and physical activity
(7) Subjects with possible food or drug allergies to the test food
(8) Subjects who regularly consume specific health foods and dietary supplements and cannot discontinue their intake during the examination period.
Others who have been deemed ineligible to participate in this clinical trial by the responsible physician.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Kamachi |
Organization
Kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
170-8481
Address
Nutrition Clinic, Kagawa Nutrition University, Komagome, Toshima-ku, Tokyo, 170-8481, Japan.
TEL
03-3918-6181
kamachi@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Uetake |
Organization
CXwellness, Inc.
Division name
Representative Director
Zip code
173-0004
Address
2-63-9-401 Itabashi, Itabashi-ku, Tokyo, Japan
TEL
03-6915-5507
Homepage URL
uetake@cx-wellness.com
Sponsor or person
Institute
Nutrition clinic, Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
NARO Bio-oriented Technology Research Advancement Institution
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Human Research Ethics Committee of Kagawa Nutrition University
Address
3-9-21, Chiyoda, Sakado, Saitama, Japan
Tel
049-289-6041
kenshien@eiyo.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 | 02 | Month | 03 | 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
| 2024 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | 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 | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061053
