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
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
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
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
