UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029131
Receipt number 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 14:10:51

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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 or person

Institute

Juntendo University, Graduate School of Health & Sports Science

Institute

Department

Personal name



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

Value
https://center6.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