UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001173 |
|---|---|
| Receipt number | R000001413 |
| Scientific Title | Clinical trial to investigate the effect of long-term intake of tomato juice on atherosclelosis |
| Date of disclosure of the study information | 2008/06/08 |
| Last modified on | 2012/08/23 17:11:53 |
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Basic information
Public title
Clinical trial to investigate the effect of long-term intake of tomato juice on atherosclelosis
Acronym
Clinical trial of long-term intake of tomato juice
Scientific Title
Clinical trial to investigate the effect of long-term intake of tomato juice on atherosclelosis
Scientific Title:Acronym
Clinical trial of long-term intake of tomato juice
Region
| Japan |
Condition
Condition
Metabolic symdrome
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of long-term intake of tomato juice on atherosclelosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Parameters of atherosclerosis (flow-mediated dilatation(FMD), blood endothelial progenitor cells (CD34/45/133/VEGFR), oxidized-LDL, inflammatory cytokines, highly-reactive CRP)
Key secondary outcomes
1) Serum total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol
2) FBS, HbA1c
3) Blood pressure, body weight, body fat parcentage, waist, BMI
4) Biomarkers; serum carotenoids, urine 8-OHdG, isoprostane, PAI-1, TNF-alfa, adiponectin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Long-term intake of tomato juice with lycopene
Interventions/Control_2
Long-term intake of tomato serum juice without lycopene
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Is over 50 years old and meets at least one of the followings; Serum triglycerides >= 150mg/dl and/or serum HDL-cholesterol< 40mg/dl, Systolic blood pressure >= 130mmHg and/or diastolic blood pressure >= 85mmHg, FBS >= 110mg/dl and/or BS >= 140mg/dl and/or HbA1c >= 5.8%
2) To whom follow up will be possible in out-patient clinic or in other appropriate ways for 9 months
3) No alterations will be required for the medication for hypertension, lipid disorder and/or diabetes mellitus in the study period
Key exclusion criteria
1) Has a history of malignant diseases and/or present malignant diseases
2) To whom pharmaceutical agents should be considered for hypertension, lipid disorder and/or diabetes mellitus
3) Has a overt systemic disease
4) Has a history of allergy to tomato
5) Has a history of cardiovascular events (cerebrovascular diseases, ischemic heart disease), has been receiving anti-platelet agents, anti-coagrants
6) Is a participant in other clinical trial
7) Is not appropriate in the investigators' opinion
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Akaike |
Organization
Tokushima University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-50-1 Kuramoto-cho, Tokushima
TEL
088-633-7851
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiho Sato |
Organization
Tokushima University Hospital
Division name
Clinical Trial Center for Developmental Therapeutics
Zip code
Address
2-50-1 Kuramoto-cho, Tokushima
TEL
088-633-9294
Homepage URL
awachiken@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Food Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 06 | Month | 08 | 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
| 2008 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 04 | Day |
Last modified on
| 2012 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001413
