UMIN-CTR Clinical Trial

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
Email	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
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041215