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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012012
Receipt No. 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

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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
Institute House Foods Corporation
Institute
Department

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
URL(English) https://upload.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


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