UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036177 |
|---|---|
| Receipt number | R000041215 |
| Scientific Title | Evaluation of cognitive function maintenance or improvement effect of propolis-containing food in healthy adults |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2021/03/11 09:37:09 |
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Basic information
Public title
Evaluation of cognitive function maintenance or improvement effect of propolis
Acronym
Evaluation of cognitive function maintenance or improvement effect of propolis
Scientific Title
Evaluation of cognitive function maintenance or improvement effect of propolis-containing food in healthy adults
Scientific Title:Acronym
Evaluation of cognitive function maintenance or improvement effect of propolis-containing food in healthy adults
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the maintenance or improvement effect of cognitive function and the safety when the elderly subjects take propolis for 24 weeks.
Efficacy is confirmed by comparing the cognitive function score of the propolis group and the placebo group in 24 weeks after taking. Also, confirm safety by evaluating physiological test, hematological test, blood biochemical test, urinalysis and adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitrax (total score of verbal memory, visual memory, finger swing, SDC, stroop, attention shift, persistent processing and 4 part sustained processing)
Measuring before intake and 24 weeks after intake.
Key secondary outcomes
MMSE, VAS on forgetfulness and markers related inflammation and heavy metal.
Measuring before intake and 24 weeks after intake.
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
Placebo
Intake: 0 mg
Ingesion: 168 days
Interventions/Control_2
Propolis
Intake: 542.88 mg
Ingesion: 168 days
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese men and women aged greater than or equal to 60 years, less than 80 years at the time of obtaining informed consent.
2. Subjects with MMSE score of 24 to 29 at screening.
3. Subjects who have subjective forgetfulness or have been pointed out forgetfulness by others.
4. Subjects who normally take three meals a day.
5. Subjects who got adequate explanation about the purpose and details of the examination, have the capacity to consent, voluntarily participate in understanding, and agree to participate in the examination in writing.
Key exclusion criteria
1. Subjects who judged by a doctor as dementia.
2. Subjects who have taken or had taken drugs of dementia or drugs affecting cognitive function
3. Subjects who have current medical history or past medical history of mental disorders (including depressive symptoms) or cerebrovascular diseases.
4. Subjects who regularly use supplements or health foods that may affect cognitive functions.
5. Subjects who judged inappropriate as subjects as a result of clinical examination of screening 1 or brain MRI examination of screening 2.
6. Subjects who were extremely irregular in their lifestyle such as meals or sleeping.
7. Subjects who have a history of asthma or current medical history.
8. Subjects who have allergies to bee products (honey etc.), conifers, trees of Pinaceae, poplar and salicylic acid.
9. Subjects who have history of alcohol dependence or current medical history.
10. Subjects who consume a large amount of alcohol routinely
11. Subjects who have serious illness or medical history such as diabetes, liver disease, kidney disease, heart disease.
12. Subjects who have medical history or history of food allergies or current medical history.
13. Subjects who have take warfarin potassium
14. Subjects who have gerontological depression scale (GDS-S-J) score of 6 or more
15. Subjects who have color vision disorder and can not easily hear people's talk at short distance.
16. Subjects who have problems with the functions of both hands due to injury, surgery, etc.
17. Participating in other food intake, testing using medicines, applying cosmetics and medicines etc, person participating in other studies during participation in this study, consent acquisition within 1 month For other exams Participants
18. Others who judged that the investigator is inappropriate as the subject
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
Shibaura OMODAKA Bldg. 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Immunological Analysis. Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihonbashi Cardiovascular Department Clinic Ethics Committee
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
yiwama@ well-sleep.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
| 2021 | Year | 01 | 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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 12 | Day |
Last modified on
| 2021 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041215
