UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020210
Receipt number 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 22:00:16

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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 or person

Institute

Kasaoka City Hospital

Institute

Department

Personal name



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

Value
https://center6.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