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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020210
Receipt No. R000023327
Scientific Title Effects of isohumulones on endothelial function in healthy volanteers
Date of disclosure of the study information 2015/12/16
Last modified on 2017/02/21

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Basic information
Public title Effects of isohumulones on endothelial function in healthy volanteers
Acronym Effects of isohumulones
Scientific Title Effects of isohumulones on endothelial function in healthy volanteers
Scientific Title:Acronym Effects of isohumulones
Region
Japan

Condition
Condition healthy, cardiovasucular disease
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate for the improvement ofimprovement of endothelial functions after oral ingestion of isohumulones, bitter components of beer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Flow mediated dilatation(FMD) in same day
Key secondary outcomes glucose, insulin, triglyceride,

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 intake placebo
washout 2days
Intake Hop cupsels which contains isohumulones about 10mg/10kg
Interventions/Control_2 Intake Hop cupsels which contains isohumulones about 10mg/10kg
washout(2days)
intake 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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male
Key inclusion criteria healthy volanteers
Key exclusion criteria none
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junko Tomita
Organization Kasaoka City Hospital
Division name Cardiology
Zip code
Address Kasaoka 5628-1 Kasaoka City
TEL 0865-63-2191
Email tomita-j@kasaokacityhsp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junko Tomita
Organization Kasaoka city Hospital
Division name Cardiology
Zip code
Address Kasaoka 5628-1, Kasaoka city
TEL 0865-63-2191
Homepage URL
Email tomita-j@kasaokacityhsp.jp

Sponsor
Institute Kasaoka City Hospital
Institute
Department

Funding Source
Organization Ksaoka City Hospital
Organization
Division
Category of Funding Organization Self funding
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 笠岡市立市民病院(岡山県)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Twelve cigarette smokers and eleven non-smokers ingested IHE and placebo in a randomized crossover design. Flow-mediated vasodilatation (FMD) was measured using ultrasonography. The FMDs increased significantly after IHE ingestion in both the smokers and the non- smokers. Oral ingestion of IHE appears to exert acute beneficial effects on the endothelial functions in both the smokers and non-smokers.
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
2015 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 16 Day
Last follow-up date
2016 Year 03 Month 16 Day
Date of closure to data entry
2016 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 15 Day
Last modified on
2017 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023327

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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