UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033505
Receipt number R000038180
Scientific Title The effects of improvement of function of high density lipoprotein cholesterol, endothelial function, and suppressioun of oxidative stress by lycopene supplement after cardiac rehabilitation.
Date of disclosure of the study information 2018/07/30
Last modified on 2020/07/31 13:10:45

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Basic information

Public title

The effects of improvement of function of high density lipoprotein cholesterol, endothelial function, and suppressioun of oxidative stress by lycopene supplement after cardiac rehabilitation.

Acronym

The effects of lycopene supplement after cardiac rehabilitation

Scientific Title

The effects of improvement of function of high density lipoprotein cholesterol, endothelial function, and suppressioun of oxidative stress by lycopene supplement after cardiac rehabilitation.

Scientific Title:Acronym

The effects of lycopene supplement after cardiac rehabilitation

Region

Japan


Condition

Condition

cardiovascular disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The effect of improvement of function of high density lipoprotein, endothelial function and suppression of oxidative stress by lycopene supplemant

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Efflux capacity of high density lipoprotein after 3 months intake

Key secondary outcomes

Superoxide dismutase activity, thiobarbituric acid reactive substance, lipid profile, BNP, NT-pro BNP, muscle volume, muscular strength, endothelial function by FMD, vessel function by PASESA and nico, exercise tolerance by CPX, physical activities after 3 months intake


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Group which intakes lycopene supplement at one dose per day during 3 months

Interventions/Control_2

Group which does not intake lycopene supplement during 3 months

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


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who suffered from cardiovascular diseases, has visited cardiac rehabilitation at least once a week in Fukuoka university hospital, is less daily lycopene intake by food than determined amount, and does not have an allergy of soy or gelatin which is component of lycopene supplement are included.

Key exclusion criteria

The patients who intakes lycopene a lot or has an allergy of soy or gelatin are excluded.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shin-ichiro Miura

Organization

Fukuoka University

Division name

Cardiology

Zip code


Address

7-45-1, Nanakuma, Jonan-ku, Fukuoka, FUkuoka, Japan

TEL

092-801-1011

Email

miuras@cis.fukuoka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasunori Suematsu

Organization

Fukuoka University

Division name

Cardiology

Zip code


Address

7-45-1, Nanakuma, Jonan-ku, Fukuoka, FUkuoka, Japan

TEL

092-801-1011

Homepage URL


Email

ysuematsu@fukuoka-u.ac.jp


Sponsor or person

Institute

Department of Cardiology, school of Medicine, Fukuoka University

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiology, school of Medicine, Fukuoka University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

福岡大学病院(福岡県)


Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 30 Day


Related information

URL releasing protocol

None

Publication of results

Unpublished


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

0

Results

This study was cancelled the approval due to the matter for specific Institutional Review Board.

Results date posted

2020 Year 07 Month 31 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

None

Participant flow

None

Adverse events

None

Outcome measures

None

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2018 Year 07 Month 15 Day

Date of IRB

2018 Year 07 Month 15 Day

Anticipated trial start date

2018 Year 08 Month 01 Day

Last follow-up date

2019 Year 02 Month 28 Day

Date of closure to data entry

2019 Year 02 Month 28 Day

Date trial data considered complete

2019 Year 02 Month 28 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 07 Month 25 Day

Last modified on

2020 Year 07 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038180


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name