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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name