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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043304
Receipt No. R000049442
Scientific Title Effects of regular honey ingestion on arterial function.
Date of disclosure of the study information 2021/02/12
Last modified on 2021/02/11

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Basic information
Public title Effects of regular honey ingestion on arterial function.
Acronym Effects of regular honey ingestion.
Scientific Title Effects of regular honey ingestion on arterial function.
Scientific Title:Acronym Effects of regular honey ingestion.
Region
Japan

Condition
Condition Healthy young adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of regular honey ingestion on arterial function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Arterial stiffness (after 4 weeks)
Key secondary outcomes Flow-mediated dilation (after 4 weeks)

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Behavior,custom
Interventions/Control_1 Control-Water ingestion (0g/day)
Interventions/Control_2 Intervention 1-Normal honey ingestion (40g/day)
Interventions/Control_3 Intervention 1-Kirghiz honey ingestion (40g/day)
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 18 years and older men and women, not restricted by a doctor from exercising, not have medic ation and smoking.
Key exclusion criteria Have cancer, diabetes, cardiovascular, and cerebrovascular diseases.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Nishiwaki
Organization Osaka Institute of Technology
Division name Faculty of Engineering
Zip code 535-8585
Address 5-16-1 Ohmiya, Asahi-ku, Osaka
TEL 06-6954-4391
Email masato.nishiwaki@oit.ac.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Nishiwaki
Organization Osaka Institute of Technology
Division name Faculty of Engineering
Zip code 535-8585
Address 5-16-1 Ohmiya, Asahi-ku, Osaka
TEL 06-6954-4391
Homepage URL
Email masato.nishiwaki@oit.ac.jp

Sponsor
Institute Center for Research Administration and Social Outreach, Osaka Institute of Technology.
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Human Ethics Committee at the Osaka Insti tute of Technology
Address 5-16-1 Ohmiya, Asahi-ku, Osaka
Tel 06-4300-6883
Email Kenkyu@josho.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
2021 Year 02 Month 12 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 22 Day
Date of IRB
2020 Year 07 Month 20 Day
Anticipated trial start date
2021 Year 02 Month 15 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
2021 Year 09 Month 30 Day
Date trial data considered complete
2021 Year 12 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 02 Month 11 Day
Last modified on
2021 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049442

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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