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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029131
Receipt No. R000033311
Scientific Title The effects of oleic acid rich peanut product on serum lipid: a double-blind, randomized controlled trial.
Date of disclosure of the study information 2017/09/24
Last modified on 2018/03/27

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Basic information
Public title The effects of oleic acid rich peanut product on serum lipid: a double-blind, randomized controlled trial.
Acronym The effects of oleic acid rich peanut product on serum lipid.
Scientific Title The effects of oleic acid rich peanut product on serum lipid: a double-blind, randomized controlled trial.
Scientific Title:Acronym The effects of oleic acid rich peanut product on serum lipid.
Region
Japan

Condition
Condition hyperlipidemia
Classification by specialty
Endocrinology and Metabolism Adult
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
40 years-old <
Age-upper limit
76 years-old >
Gender 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
1st name
Middle name
Last name Yoshio Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code
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
1st name
Middle name
Last name Yoshio Suzuki
Organization Juntendo University
Division name Graduate School of Health & Sports Science
Zip code
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
2. Chiba Prefectural Agriculture Forestry Research Center
3. Yachimata Peanuts Commerce and Industry Cooperative
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 兒玉病院(千葉県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 24 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 Completed
Date of protocol fixation
2017 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 13 Day
Last modified on
2018 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033311

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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