UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050328 |
|---|---|
| Receipt number | R000057216 |
| Scientific Title | Effect of Cumin Essential Oil (Cuminaldehyde) intake on Cognitive Function in the Elderly: A 12-Week Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2025/03/18 05:01:47 |
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Basic information
Public title
Effect of Cumin Essential Oil (Cuminaldehyde) intake on Cognitive Function in the Elderly: A 12-Week Randomized Controlled Trial
Acronym
Effects of Cumin Essential Oil Intake on Cognitive Function
Scientific Title
Effect of Cumin Essential Oil (Cuminaldehyde) intake on Cognitive Function in the Elderly: A 12-Week Randomized Controlled Trial
Scientific Title:Acronym
Effects of Cumin Essential Oil Intake on Cognitive Function
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to elucidate the effects on cognitive function of daily cumin essential oil (Cuminaldehyde) ingestion for 12 weeks in elderly by a randomized controlled trial. The primary outcome is cognitive function, and secondary outcome measures are blood biomarkers (amyloid-beta and brain-derived neurotrophic factor (BDNF)).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Cognitive function test
Key secondary outcomes
Blood concentration of amyloid 1-40
Blood concentration of amyloid 1-42
Brain-derived neurotrophic factor
"Trail making peg" test
Geriatric Depression Scale
Pittsburgh Sleep Quality Index
Profile of Mood States 2nd Edition
Physical Activity Scale for the Elderly
SF8 Health Survey
d-ROMs
BAP
Body composition measured by bioelectrical impedance analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Group that take 25 mg of cumin aldehyde daily
Interventions/Control_2
Placebo group
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
| 65 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Persons between the ages of 65 and 89 at the time the consent form is obtained.
(2)Those who do not have a history of diabetes, cerebrovascular disease, cardiovascular disease, cancer, or paralysis
(3)Those who can in take cumin essential oil (no allergies or rejection)
(4)Those who have no allergy or rejection to gelatin.
(5)Those who regularly consume curry powder-based foods daily but can adjust their intake to 2-3 times.
(6)Those who have not participated or are not currently participating in any other clinical research within the past 3 months.
(7)Those who fully understand the content of this study and are able to commute to the study site on their own.
Key exclusion criteria
Subjects with dementia (MMSE<-23 points) and depressions (GDS>-11 points).
And/or are taking these medications
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Okura |
Organization
University of Tsukuba
Division name
Faculty of Health and sport science
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-2733
okura.tomohiro.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Okura |
Organization
University of Tsukuba
Division name
Faculty of Health and sport science
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-2733
Homepage URL
okura.tomohiro.gp@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
N.A.
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
University of Tsukuba, Faculty of Health and sport science, Research Ethics Committee
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
+81-029-853-2571
tg-kenkyurinri@un.tsukuba.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 | 05 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057216
