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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027126
Receipt No. R000031087
Scientific Title Effect of dietary trans fatty acid level on serum lipid concentration
Date of disclosure of the study information 2017/05/01
Last modified on 2019/05/16

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Basic information
Public title Effect of dietary trans fatty acid level on serum lipid concentration
Acronym Effect of 1.5%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 1.5%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 NO

Objectives
Narrative objectives1 To investigate effect of 1.5%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 1.5%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 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Takeuchi
Organization Toyama College
Division name Food and nutrition
Zip code
Address 444 mizuguchi, gankai-zi, Toyama-shi, Toyama
TEL 076-436-5168
Email wistar1111@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Takeuchi
Organization Toyama College
Division name Food and nutrition
Zip code
Address 444 mizuguchi, gankai-zi, Toyama-shi, Toyama
TEL 076-436-5168
Homepage URL
Email wistar1111@gmail.com

Sponsor
Institute Toyama College
Institute
Department

Funding Source
Organization

Kieikai Research Foundation
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 04 Month 28 Day
Date of IRB
2017 Year 04 Month 28 Day
Anticipated trial start date
2017 Year 04 Month 28 Day
Last follow-up date
2020 Year 03 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 25 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031087

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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