UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061111 |
|---|---|
| Receipt number | R000069932 |
| Scientific Title | Study on the synergistic effects of oral intake of ferulic acid and gamma-oryzanol from rice bran components and an exercise program on cognitive function in older adults |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/31 12:01:55 |
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Basic information
Public title
Effects of ferulic acid, gamma-oryzanol, and an exercise program on cognitive function in healthy older adults
Acronym
FA/GO cognitive intervention study in older adults
Scientific Title
Study on the synergistic effects of oral intake of ferulic acid and gamma-oryzanol from rice bran components and an exercise program on cognitive function in older adults
Scientific Title:Acronym
Ferulic acid, gamma-oryzanol, and exercise study for cognitive function in older adults
Region
| Japan |
Condition
Condition
Age-related decline in cognitive function and health maintenance in healthy older adults
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine whether intake of ferulic acid and gamma-oryzanol, together with participation in an exercise program, can maintain or improve cognitive function, health status, and physical fitness in older adults. Participants will also be followed 6 months after the end of intake to evaluate the persistence of the effects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in cognitive function assessed by Cognitrax. The primary evaluation focuses on changes from baseline to week 12. Assessments are performed at baseline, week 6, week 12, and 6 months after the end of intake.
Key secondary outcomes
Changes in subjective cognitive status assessed by the Visual Analogue Scale (VAS), physical fitness measures, anthropometric measures, blood pressure, blood biochemical parameters, and health questionnaire outcomes will be evaluated. Blood tests are performed only at baseline and after 12 weeks.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Arm A: Non-exercise plus placebo capsule group. Participants orally take 4 placebo soft capsules daily for 12 weeks. No specific exercise program is provided, and participants continue their usual daily life.
Interventions/Control_2
Arm B: Non-exercise plus active capsule group. Participants orally take 4 active soft capsules daily for 12 weeks. The active capsules contain ferulic acid 300 mg/day and rice germ oil GX-N 150 mg/day, corresponding to approximately 45 mg/day of gamma-oryzanol. No specific exercise program is provided, and participants continue their usual daily life.
Interventions/Control_3
Arm C: Exercise program plus placebo capsule group. Participants orally take 4 placebo soft capsules daily for 12 weeks. In addition, they participate in a 90-minute supervised group exercise session once weekly for 12 weeks at the Wakayama University gymnasium and perform similar exercises at home every day. The exercise program consists of warm-up exercises, stretching, step exercise, chair-based simple resistance training, and recreation.
Interventions/Control_4
Arm D: Exercise program plus active capsule group. Participants orally take 4 active soft capsules daily for 12 weeks. The active capsules contain ferulic acid 300 mg/day and rice germ oil GX-N 150 mg/day, corresponding to approximately 45 mg/day of gamma-oryzanol. In addition, they participate in a 90-minute supervised group exercise session once weekly for 12 weeks at the Wakayama University gymnasium and perform similar exercises at home every day.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy men and women aged 60 to 84 years
2. Individuals judged healthy based on a medical interview or examination by a physician
3. Individuals not using medications or supplements expected to influence the study outcomes
4. Individuals who receive a full explanation of the study, understand the study, and can provide written informed consent
5. Individuals who are able to attend the scheduled visits and undergo the required assessments
6. Individuals judged eligible for participation by a physician
Key exclusion criteria
1. Individuals judged unsuitable for participation by a physician
2. Individuals unable to attend the scheduled visits
3. Individuals using medications or supplements expected to influence the study outcomes
4. Individuals unable to understand the study or provide written informed consent
5. Individuals not cleared for participation in the exercise component based on the pre-study medical check-up
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mitsugi |
| Middle name | |
| Last name | Motoyama |
Organization
Wakayama University
Division name
Wakayama University Headquarters
Zip code
640-8510
Address
930 Sakaedani, Wakayama, Wakayama 640-8510, Japan
TEL
073-457-7309
motoyama@wakayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsugi |
| Middle name | |
| Last name | Motoyama |
Organization
Wakayama University
Division name
Wakayama University Headquarters
Zip code
640-8510
Address
930 Sakaedani, Wakayama, Wakayama 640-8510, Japan
TEL
073-457-7309
Homepage URL
https://www.wakayama-u.ac.jp/cijr/
motoyama@wakayama-u.ac.jp
Sponsor or person
Institute
Wakayama University
Institute
Department
Personal name
Mitsugi Motoyama
Funding Source
Organization
Tsuno Group Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tsuno Rice Fine Chemicals Co., Ltd.; Koyasan University
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Wakayama University Research Ethics Committee
Address
930 Sakaedani, Wakayama, Wakayama 640-8510, Japan
Tel
073-457-7564
kenkyo@ml.wakayama-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
None
Org. issuing International ID_1
None
Study ID_2
Org. issuing International ID_2
IND to MHLW
該当なし
Institutions
Institutions
和歌山大学（体育館、学内講義棟、松下会館講義室、学内研究室等）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
Follow-up ongoing
Number of participants that the trial has enrolled
191
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 | 04 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 31 | Day |
Last modified on
| 2026 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069932
