UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032719 |
|---|---|
| Receipt number | R000037310 |
| Scientific Title | Effect of dietary trans fatty acid level on serum lipid concentration |
| Date of disclosure of the study information | 2018/05/31 |
| Last modified on | 2022/04/28 18:12:25 |
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Basic information
Public title
Effect of dietary trans fatty acid level on serum lipid concentration
Acronym
Effect of 2%E 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 2%E 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 2%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
Serum lipid levels, after 4 weeks
Key secondary outcomes
Diabetes markers, 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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Control group
Period: 4 weeks
Intervention: Supplement of less than 0.1%E trans fatty acids in addition to regular diet every day
Interventions/Control_2
Trans fatty acid group
Period: 4 weeks
Intervention: Supplement of 2%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
Female
Key inclusion criteria
General healthy women
Key exclusion criteria
Patients under treatment of dyslipidemia and diabetes
Target sample size
70
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
9310193
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
Toyama College
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
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
| 2018 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://endai.umin.ac.jp/cgi-open-bin/ojac/search/ojac_search.cgi?cond=%27A00093-00031-10007%27&parm
Publication of results
Published
Result
URL related to results and publications
https://endai.umin.ac.jp/cgi-open-bin/ojac/search/ojac_search.cgi?cond=%27A00093-00030-10008%27&parm
Number of participants that the trial has enrolled
39
Results
There were no significant differences in total cholesterol, LDL-cholesterol, HDL-cholesterol, blood glucose levels, or HbA1c between the control group and the trans acid group. Compared with the control group, the trans acid group showed significantly higher values in triglyceride and insulin. The amount of trans acid in erythrocytes of the trans acid group was significantly higher than that of the control group.
Results date posted
| 2022 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adult women in their 20s and 60s
Participant flow
Forty-four people wanted to participate, but two people declined on the way due to personal reasons. A blood test revealed that three people needed treatment.
Adverse events
none
Outcome measures
LDL-cholesterol, HDL-cholesterol, blood glucose, HbA1c, triglycerides, insulin
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 25 | Day |
Last modified on
| 2022 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037310
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| Registered date | File name |
| Research case data | |
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