UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012012
Receipt number R000011490
Scientific Title A randomized crossover clinical study to determine the effects of acute intake of curry on postprandial endothelial function in healthy men
Date of disclosure of the study information 2013/10/30
Last modified on 2013/10/10 16:01:42

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Basic information

Public title

A randomized crossover clinical study to determine the effects of acute intake of curry on postprandial endothelial function in healthy men

Acronym

Clinical study of the effects of curry on postprandial endothelial function

Scientific Title

A randomized crossover clinical study to determine the effects of acute intake of curry on postprandial endothelial function in healthy men

Scientific Title:Acronym

Clinical study of the effects of curry on postprandial endothelial function

Region

Japan


Condition

Condition

Postprandial endothelial dysfunction in healthy men

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine whether a single consumption of curry would improve endothelial function in healthy men.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Flow-mediated vasodilation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

A single consumption of curry meal

Interventions/Control_2

A single consumption of spice-free control meal

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

70 years-old >=

Gender

Male

Key inclusion criteria

Healthy men who agree the study design and protocol

Key exclusion criteria

(1) Subjects who usually intake the foods which are added spices or antioxidant.
(2) Subjects who are implanted arteriorvenous shunts
(3) Subjects who are judged as unsuitable by questionnaires about their lifestyle
(4) Patients during any therapy
(5) Subjects who may have allergies caused by test meal (curry)
(6) Subjects who have a past history of critical illness such as diabetes mellitus, hepatic disease, kidney disease or cardiac disease and so on
(7) Subjects who have participated in other clinical study
(8) Subjects whose fasting FMD was less than 4%

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideki Nakayama

Organization

House Foods Corporation

Division name

SOMATECH center

Zip code


Address

1-4, Takanodai, Yotsukaido, Chiba, Japan

TEL

043-237-5211

Email

hideki-nakayama@housefoods.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Nakayama

Organization

House Foods Corporation

Division name

SOMATECH center

Zip code


Address

1-4, Takanodai, Yotsukaido, Chiba, Japan

TEL

043-237-5211

Homepage URL


Email

hideki-nakayama@housefoods.co.jp


Sponsor or person

Institute

House Foods Corporation

Institute

Department

Personal name



Funding Source

Organization

House Foods Corporation

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

ハウス食品株式会社ソマテックセンター


Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 30 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

Completed

Date of protocol fixation

2012 Year 12 Month 06 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 10 Month 10 Day

Last modified on

2013 Year 10 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011490


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name