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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015423
Receipt No. R000017915
Scientific Title The prevention of Alzheimer's disease through regulation of amyloid beta synthesis and brake-down by propolis intake
Date of disclosure of the study information 2014/10/14
Last modified on 2018/10/20

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Basic information
Public title
The prevention of Alzheimer's disease through regulation of amyloid beta synthesis and brake-down by propolis intake
Acronym The prevention of Alzheimer's disease by propolis intake
Scientific Title
The prevention of Alzheimer's disease through regulation of amyloid beta synthesis and brake-down by propolis intake
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshinori Marunaka
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name Department of Molecular Cell Physiology
Zip code
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
1st name
Middle name
Last name Shinobu Matsumoto
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name Department of Endocrinology and Metabolism
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Terminated
Date of protocol fixation
2014 Year 06 Month 25 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000017915

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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