UMIN-CTR Clinical Trial

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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