UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026010
Receipt number R000029787
Scientific Title The effect of intake of Cirsium brevicaule on lipid metabolism
Date of disclosure of the study information 2017/04/01
Last modified on 2018/04/18 12:00:13

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Basic information

Public title

The effect of intake of Cirsium brevicaule on lipid metabolism

Acronym

The effect of intake of Cirsium brevicaule on lipid metabolism

Scientific Title

The effect of intake of Cirsium brevicaule on lipid metabolism

Scientific Title:Acronym

The effect of intake of Cirsium brevicaule on lipid metabolism

Region

Japan


Condition

Condition

healthy subject

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will examine the impact on lipid metabolism of the Cirsium brevicaule.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The test verifies the change over time in the total cholesterol, triglyceride, LDL cholesterol, HDL cholesterol, body weight, body fat and Body Mass Index. (Before intake, after intake 4weeks, after intake 8weeks and after intake 12weeks.)

Key secondary outcomes

The test verifies the change in the serum adiponectin and other biochemical indicators.(Before intake, after intake 4weeks, after intake 8weeks and after intake 12weeks.)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Subjects takes the 12-week test food. The evaluation is carried out every four weeks.

Interventions/Control_2


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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1.Japanese men and women from 20 years old to 80 years old
2.Those who fully understand and document agreed by free will of the subject person was obtained after having received a sufficient explanation of the study
3.Below, corresponding to either subjects
*LDL cholesterol level is borderline and person of mild range (120-159mg/dl)
*Who triglyceride levels of the high-normal range, and slightly higher (120-199mg/dl)

Key exclusion criteria

1.Those who are routinely regular use "Cirsium brevicaule"
2.Taking medicine for dyslipidemia
3.Excessive smoking and alcohol addicts as well as the diet is extremely irregular person
4.Those of serious diseases currently in treatment
5.Diabetes, liver disease, kidney disease, who underlying disease, such as heart disease that need is urgent treatment in serious condition
6.Those with a history of food allergies
7.A person with a plan of pregnancy during the lactation period and the person or test period during pregnancy
8.A person who has been determined to be inappropriate as a subject in the results of the screening
9. Other, who investigators were ineligible

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Ohno

Organization

Osaka University Graduate School of Medicine

Division name

Department of Integrative Medicine

Zip code


Address

2-2, Yamadaoka, Suita, OSAKA

TEL

06-6879-3498

Email

ohno@cam.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Miki Sakaue

Organization

Osaka University Graduate School of Medicine

Division name

Department of Integrative Medicine

Zip code


Address

2-2, Yamadaoka, Suita, OSAKA

TEL

06-6879-3498

Homepage URL


Email

mikity@cam.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Integrative Medicine, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Cabinet Office Regional Creation Promotion Grant "Tokunoshima Kagoshima prefecture"

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


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



Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 01 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 02 Month 08 Day

Date of IRB


Anticipated trial start date

2017 Year 07 Month 07 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 02 Month 06 Day

Last modified on

2018 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029787


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name