UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013579 |
|---|---|
| Receipt number | R000015866 |
| Scientific Title | Intervention trial of beta-cryptoxanthin-rich satsuma mandarin juice |
| Date of disclosure of the study information | 2014/03/31 |
| Last modified on | 2017/03/21 11:39:47 |
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Basic information
Public title
Intervention trial of beta-cryptoxanthin-rich satsuma mandarin juice
Acronym
Intervention trial of beta-cryptoxanthin-rich satsuma mandarin juice
Scientific Title
Intervention trial of beta-cryptoxanthin-rich satsuma mandarin juice
Scientific Title:Acronym
Intervention trial of beta-cryptoxanthin-rich satsuma mandarin juice
Region
| Japan |
Condition
Condition
atherosclerosis
metabolic syndrome
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate an effect of beta-cryptoxanthin-rich satsuma mandarin juice on atherosclerosis and metabolic syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) pulse wave velocity
2) MDA-oxLDL
Key secondary outcomes
1) hsCRP,IL-6
2) adiponectin
3) insulin,FBS,HOMA index,HbA1c
4) blood pressure
5) AST,ALT,GGTP
6) LDL-C,HDL-C,TG
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Beta-cryptoxanthin-rich (4mg) satsuma mandarin juice for 12 weeks
Interventions/Control_2
Non beta-cryptoxanthin (0mg) satsuma mandarin juice for 12 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
| 25 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Participants of specified health check-up
Key exclusion criteria
1) Eat satsuma mandarin everyday between October and February.
2) History of stroke, myocardial infarction, cancer and aneurism.
3) Being treated with diet therapy by physician.
4) Plan to quit smoking within 3 months.
5) Taking antihypertensives.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | NAKAMURA Mieko |
Organization
Hamamatsu University School of Medicine
Division name
Department of Community Health and Preventive Medicine
Zip code
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2333
miekons@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | NAKAMURA Mieko |
Organization
Hamamatsu University School of Medicine
Division name
Department of Community Health and Preventive Medicine
Zip code
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2333
Homepage URL
miekons@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
| 2014 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://authors.elsevier.com/sd/article/S2352385916300226
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
| 2014 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 31 | Day |
Last modified on
| 2017 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015866
