UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013532 |
|---|---|
| Receipt number | R000015820 |
| Scientific Title | Effects of Almond on atherosclerosis risk factor |
| Date of disclosure of the study information | 2014/03/28 |
| Last modified on | 2014/03/27 17:14:30 |
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Basic information
Public title
Effects of Almond on atherosclerosis risk factor
Acronym
Effects of Almond on atherosclerosis risk factor
Scientific Title
Effects of Almond on atherosclerosis risk factor
Scientific Title:Acronym
Effects of Almond on atherosclerosis risk factor
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of almond
on atherosclerosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose, insulin, serum lipids, oxidative stress maker
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
0 g of almond
Interventions/Control_2
28 g of almond
Interventions/Control_3
56 g of almond
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
Subjects who are competent to consent
Key exclusion criteria
Subjects who are judged by the doctor as
not eligible to this study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Kondo |
Organization
Ochanomizu University
Division name
Institute of Environmental Science for Human Life
Zip code
Address
2-1-1 Otsuka, Bunkyo-ku, Tokyo
TEL
03-5978-5812
kondo.kazuo@ocha.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Kondo |
Organization
Ochanomizu University
Division name
Institute of Environmental Science for Human Life
Zip code
Address
2-1-1 Otsuka, Bunkyo-ku, Tokyo
TEL
03-5978-5812
Homepage URL
kondo.kazuo@ocha.ac.jp
Sponsor or person
Institute
Ochanomizu University
Institute
Department
Personal name
Funding Source
Organization
Almond Board of California
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 28 | 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
| 2005 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 05 | Month | 01 | 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
| 2014 | Year | 03 | Month | 27 | Day |
Last modified on
| 2014 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015820
