UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The prevention of Alzheimer's disease through regulation of amyloid beta synthesis and brake-down by propolis intake
Title of the study (Brief title)	The prevention of Alzheimer's disease by propolis intake
Region	Japan

Condition
Condition	type 2 diabetes dementia
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the effects of Propolis for prevention of Alzheimer's disease through regulation of amyloid beta synthesis and brake-down in patients with type 2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	amyloid-beta, Tau protein, activity of the beta-amyloid converting enzyme 1
Key secondary outcomes	HbA1c, fasting plasma glucose, serum insulin, Mini-Mental State Examination

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Brazilian Propolis(450.0mg/day)
Interventions/Control_2	placebo
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients who are able to give written informed consent 2) Age is over 60 years and less than 85 years 3) MMSE score 24-27. 4) HbA1c 6.0-10.0% 5) Patients are able to do the following things in this trial - getting good compliance with consuming investigational food and coming to hospital
Key exclusion criteria	1) Patients who did not agree with this study 2) Patients with severe renal dysfunction and severe hepatic dysfunction 3) Type 1 diabetes and other specific types of diabetes resulting from specific genetic syndromes, surgery, drugs, malnutrition, infections, and other illnesses 4) Patients treated with insulin 5) Patients with dementia or neurodegenerating disease 6) Patients who is taking drugs which affect the cognitive function 7) Patients who changed oral hypoglycemic drugs significantly 8) Patients who changed drugs which affect pH of interstitial fluid 9) Patients judged by the investigator to be ineligible for some other reason
Target sample size	60

Research contact person
Name of lead principal investigator	Yoshinori Marunaka
Organization	Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name	Department of Molecular Cell Physiology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL	+81-75-251-5311
Email	marunaka@koto.kpu-m.ac.jp

Public contact
Name of contact person	Shinobu Matsumoto
Organization	Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name	Department of Endocrinology and Metabolism
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL	+81-75-251-5506
Homepage URL
Email	s-matsu3@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department

Funding Source
Organization	Yamada Apiculture Center Inc. (Okayama, Japan)
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	京都府立医科大学附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 14 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 06 Month 25 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date	2018 Year 02 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 13 Day
Last modified on	2018 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017915