UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063123 |
|---|---|
| Receipt number | R000072186 |
| Scientific Title | Evaluation of the Blood Kinetics of Maslinic Acid Following Consumption of a Food Containing Olive Fruit Extract |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/29 08:57:46 |
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Basic information
Public title
Evaluation of the Blood Kinetics of Maslinic Acid Following Consumption of a Food Containing Olive Fruit Extract
Acronym
Evaluation of the Blood Kinetics of Maslinic Acid Following Consumption of a Food Containing Olive Fruit Extract
Scientific Title
Evaluation of the Blood Kinetics of Maslinic Acid Following Consumption of a Food Containing Olive Fruit Extract
Scientific Title:Acronym
Evaluation of the Blood Kinetics of Maslinic Acid Following Consumption of a Food Containing Olive Fruit Extract
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will evaluate the blood Blood Kinetics of maslinic acid following consumption of foods containing olive fruit extract among Japanese men aged 40 to 59.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood Maslinic Acid Concentration
Key secondary outcomes
(Safety evaluation )
Physical measurements,Vital signs,Adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of test food A
Interventions/Control_2
Single intake of test food B
Interventions/Control_3
Single intake of test food C
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1.Japanese male and female subjects between 20 and 60 years of age at the time of consent.
2.Subjects who can have multiple blood draws.
3.Subjects who lead a regular life (subject who eat three meals a day at almost regular intervals).
4.Healthy subjects.
5.Subjects who have received a full explanation of the purpose and content of the study, have the ability to consent, understand the study well, and have volunteered to participate in the study and have agreed to participate in the study in writing.
Key exclusion criteria
1.Subjects who are currently receiving medication or outpatient treatment for some serious disease.
2.Subjects who are currently undergoing exercise or diet therapy under the supervision of a physician.
3.Subjects who may develop allergies to the test food.
4.Subjects who have a current or history of drug dependence or alcohol dependence.
5.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders, or have a history of mental disorders in the past.
6.Subjects who have irregular rhythm of life due to night work or shift work.
7.Subjects who are with extremely irregular eating, sleeping, or other habits.
8.Subjects who have an extremely unbalanced diet.
9.Subjects who have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, liver diseases (hepatitis), kidney diseases, heart diseases,gastrointestinal diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases.
10.Subjects who use of health foods, supplements, and medications within one month retroactive to the date consent was obtained.
11.Subjects who have participated in other clinical trials (research) within 3 months retrospectively from the date of obtaining consent, or those who have plans to participate in other clinical trials (research) during the study period
12.Subjects who have collected more than 200 mL of blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent.
13.Subjects who have difficulty in complying with the recording of various questionnaires.
14.Other subjects who are judged unsuitable as subjects by the principal investigator.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Kyouko |
| Middle name | |
| Last name | Shimadu |
Organization
Nippon Co., Ltd.
Division name
Central Research Institute, Innovation Center, Functional Materials Team
Zip code
243-0041
Address
5-1-3 Midorigaoka, Atsugi City, Kanagawa Prefecture
TEL
046-222-6963
k-shimazu@nippn.co.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
MIS Co.,Ltd.
Division name
Clinical Development Department
Zip code
531-0072
Address
8F,Sho-rei Building, 3-4-14 Toyosaki, Kitaku, Osaka-Shi, Osaka 531-0072, Japan
TEL
06-7878-6780
Homepage URL
mis_21@mis21.co.jp
Sponsor or person
Institute
MIS Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon 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
DiaStep Medical Corporation Home Doctor Clinical Research Ethics Review
Address
Morizumi Building 3F, 22-7 Taishido 4-chome, Setagaya-ku, Tokyo
Tel
03-5433-3255
tomohisa.kato@diastep.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
| 2026 | Year | 10 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072186
