UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056894 |
|---|---|
| Receipt number | R000065012 |
| Scientific Title | Safety test of the long-term intake of the lecithin addition rice. |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/02/03 10:09:28 |
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Basic information
Public title
Safety test of the long-term intake of the lecithin addition rice.
Acronym
Safety test of the long-term intake of the lecithin addition rice.
Scientific Title
Safety test of the long-term intake of the lecithin addition rice.
Scientific Title:Acronym
Safety test of the long-term intake of the lecithin addition rice.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Taking the cooking rice with lecithin for 180g per day for 12weeks. Then, we inspect subjects's safety and subjects blood glucose dynamics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood tests,
Key secondary outcomes
intestinal flora, gamma oryzanol
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
After selecting healthy subjects for screening, blood and urine samples will be collected at 4, 8, and 12 weeks after consumption of the test meal. In addition, the intestinal microbiota will be examined at screening and at 4 weeks after intake.
Interventions/Control_2
After selecting healthy subjects for screening, blood and urine samples will be collected at 4, 8, and 12 weeks after consumption of the placebo meal. In addition, the intestinal microbiota will be examined at screening and at 4 weeks after intake.
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
1.Healthy men and women between the ages of 20 and 75
2. Those who voluntarily wish to participate in the clinical trial and provide written consent
3.Patients who are able to maintain a constant daily lifestyle during the study period
4.Twenty subjects will be selected as the study subjects, mainly those who have the results of venous blood sampling test at screening, AUC (area under the curve), normal high blood glucose level group and those who have large fluctuation of blood glucose level in their daily life.
5.Those who are approved to participate by the responsible physician.
6.For matching between the two groups, gender difference and blood glucose level and BMI will be taken into consideration.
Key exclusion criteria
1.Those who suffer from serious diseases (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental disorders
2.Patients with a history of serious diseases (diabetes, heart disease, liver disease, renal disease, cancer, etc.) in the past
3. Have donated more than 200 mL of blood in the past month or 400 mL within the past 3 months.
4. Those who have experienced sickness or deterioration of physical condition due to blood collection in the past, or those who have been told that blood collection is difficult due to narrow blood vessels.
5. Those who have severe anemia symptoms
6. Those who are unable to maintain their daily lifestyle due to significant changes in diet and physical activity
7.Those with possible food or drug allergies to the test food
8. Those who take specified health foods, health foods, etc. on a daily basis and cannot stop taking them during the study period.
9.Those who are taking specified health foods, health foods, etc. on a daily basis and cannot stop taking them during the study period.
Target sample size
20
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
3-24-3, Komagome, Toshima-ku,Tokyo,Japan
TEL
03-3918-6181
clinic@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kamachi |
Organization
Kagawa Nutrition University
Division name
Nutrition clinic
Zip code
170-8481
Address
3-24-3, Komagome,Toshima-ku, Tokyo.Japan
TEL
03-3918-6181
Homepage URL
clinic@eiyo.ac.jp
Sponsor or person
Institute
NUtrition Clinic, Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
NARO Bio-oriented Technology Research Advancement Instution
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
Kagawa Nutrition University
Address
3-9-21, chiyoda,Sakadoy,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
| 2025 | Year | 02 | Month | 01 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065012
