UMIN-CTR Clinical Trial

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
Email	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
Email	wistar1111@gmail.com

Sponsor
Institute	Toyama College
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037310