UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study on the effects of oleic acid rich peanut product on serum lipid: a double-blind, randomized controlled trial.
Title of the study (Brief title)	The effects of oleic acid rich peanut product on serum lipid.
Region	Japan

Condition
Condition	hyperlipidemia
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to assess the effects of oleic acid rich peanut product on serum lipid levels in subjects with mild hyperlipidemia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum lipids
Key secondary outcomes

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	Treatment
Type of intervention	Food
Interventions/Control_1	Ingesting 40g of peanut product daily for 8 weeks
Interventions/Control_2	Ingesting 40g of oleic acid rich peanut product daily for 8 weeks
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	50 years-old <=
Age-upper limit	76 years-old >
Gender	Male and Female
Key inclusion criteria	(1) subjects fulfilling at least one of the following criteria 199<TC<260mg/dL 149<TG<400 mg/dL 119<LDL-C<180 mg/dL (2) Subjects who are not prescribed drug for hyperlipidemia.
Key exclusion criteria	(1)Subject who is prescribed drug. (2)Subject who suffers or suffered from severe cardiovascular, hepatic, renal, pulmonary, endocrine, or metabolic disorder. (3)Subject who experienced chest pain or syncope. (4)Subject who has allergy to test food. (5)Subject who donated whole blood ,200ml within 1 month or 400ml within 3 month, before entry. (6)Smokers (7)Subjects who participate in other clinical trials within the last 3 month before entry. (8)Subjects who are not eligible due to physician's judgment
Target sample size	40

Research contact person
Name of lead principal investigator	Yoshio Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
Address	1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL	+81-476-98-1001
Email	yssuzuki@juntendo.ac.jp

Public contact
Name of contact person	Yoshio Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
Address	1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL	+81-476-98-1001
Homepage URL
Email	yssuzuki@juntendo.ac.jp

Sponsor
Institute	Juntendo University, Graduate School of Health & Sports Science
Institute
Department

Funding Source
Organization	Chiba Prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	1. Kazusa DNA Research Institute Chiba Prefectural Agriculture 2. Forestry Research Center 3. Yachimata Peanuts Commerce and Industry Cooperative
Name of secondary funｄer(s)

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	2016 Year 08 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 04 Day
Anticipated trial start date	2016 Year 09 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 29 Day
Last modified on	2017 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027434