UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention trial of beta-cryptoxanthin-rich satsuma mandarin juice
Title of the study (Brief title)	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	NAKAMURA Mieko
Organization	Hamamatsu University School of Medicine
Division name	Department of Community Health and Preventive Medicine
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	053-435-2333
Email	miekons@hama-med.ac.jp

Public contact
Name of contact person	NAKAMURA Mieko
Organization	Hamamatsu University School of Medicine
Division name	Department of Community Health and Preventive Medicine
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	053-435-2333
Homepage URL
Email	miekons@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://authors.elsevier.com/sd/article/S2352385916300226
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015866