UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000033505
Receipt No. 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 (Ver. 3)

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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
Institute Department of Cardiology, school of Medicine, Fukuoka University
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038180