UMIN-CTR Clinical Trial

Basic information
Public title	The effects of dietary therapy on patients with hypertriglyceridemia
Acronym	The effects of dietary therapy on patients with hypertriglyceridemia
Scientific Title	The effects of dietary therapy on patients with hypertriglyceridemia
Scientific Title:Acronym	The effects of dietary therapy on patients with hypertriglyceridemia
Region	Japan

Condition
Condition	patients with hypertriglyceridemia
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effectiveness of long-term dietary therapy for hypertriglyceridemia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum triglyceride level(12 months from the start of nutritional guidance)
Key secondary outcomes	Body weight Serum fatty acid level Serum small dense LDL level Serum HDL cholesterol level Energy and carbohydrate intake

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with serum triglyceride levels greater than 150 mg/dl
Key exclusion criteria	Patients who are undergoing treatment for cancer patients and renal or hepatic dysfunction.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hidekazu Arai
Organization	The University of Shizuoka
Division name	Graduate School of Integrated Pharmaceutical and Nutritional Sciences
Zip code
Address	52-1 Yada, Suruga-ku, Shizuoka
TEL	054-264-5511
Email	arai@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hidekazu Arai
Organization	The University of Shizuoka
Division name	Graduate School of Integrated Pharmaceutical and Nutritional Sciences
Zip code
Address	52-1 Yada, Suruga-ku, Shizuoka
TEL	054-264-5511
Homepage URL
Email	arai@u-shizuoka-ken.ac.jp

Sponsor
Institute	The University of Shizuoka
Institute
Department

Funding Source
Organization	The University of Shizuoka
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Japan

Other related organizations
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IRB Contact (For public release)
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Tel
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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	浅井内科医院（静岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 08 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
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Results Delayed
Results Delay Reason
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Baseline Characteristics
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Adverse events
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IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date	2013 Year 03 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	12 months observation test

Management information
Registered date	2017 Year 08 Month 28 Day
Last modified on	2017 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033033

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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