UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017642 |
|---|---|
| Receipt number | R000020282 |
| Scientific Title | Effect of dietary trans fatty acid level on serum lipid concentration |
| Date of disclosure of the study information | 2015/05/22 |
| Last modified on | 2021/05/06 17:06:22 |
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Basic information
Public title
Effect of dietary trans fatty acid level on serum lipid concentration
Acronym
Effect of dietary trans fatty acids on serum lipid concentration
Scientific Title
Effect of dietary trans fatty acid level on serum lipid concentration
Scientific Title:Acronym
Effect of dietary trans fatty acids on serum lipid concentration
Region
| Japan |
Condition
Condition
Life-style related disease
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate effect of 1%E trans fatty acids on blood lipid and glucose metabolism in healthy men and women
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood lipid levels and diabetes markers
Key secondary outcomes
Cardio Ankle Vascular Index, Blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Control group
Interventions/Control_2
Trans fatty acid group
Period: 4 weeks
Intervention: Supplement of 1%E trans fatty acids in addition to regular diet every day
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
General healthy men and women
Key exclusion criteria
Patients under treatment of dyslipidemia and diabetes
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takeuchi |
Organization
Toyama College
Division name
Food and nutrition
Zip code
930-0193
Address
444 mizuguchi, gankai-zi, Toyama-shi, Toyama
TEL
076-436-5168
wistar1111@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takeuchi |
Organization
Toyama College
Division name
Food and nutrition
Zip code
930-0193
Address
444 mizuguchi, gankai-zi, Toyama-shi, Toyama
TEL
076-436-5168
Homepage URL
wistar1111@gmail.com
Sponsor or person
Institute
Toyama College
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama College
Address
444 Mizugchi Gankaiji Toyama
Tel
076-436-5176
kyoumu@toyama-c.ac.jp
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
| 2015 | Year | 05 | Month | 22 | 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
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 | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 21 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020282
