UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002682
Receipt No. R000003267
Scientific Title Clinical trial to investigate the effect of intake of sudachi peel on risk factor of metabolic syndrome
Date of disclosure of the study information 2009/10/28
Last modified on 2010/10/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical trial to investigate the effect of intake of sudachi peel on risk factor of metabolic syndrome
Acronym Clinical trial of intake of sudachi peel
Scientific Title Clinical trial to investigate the effect of intake of sudachi peel on risk factor of metabolic syndrome
Scientific Title:Acronym Clinical trial of intake of sudachi peel
Region
Japan

Condition
Condition Metabolic syndrome
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of intake of sudachi peel on risk factors of metabolic syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Triglyceride
Fasting plasma glucose
Key secondary outcomes 1)LDL-cholesterol, HDL-cholesterol,
RLP-cholesterol, free fatty acid
2)HbA1c, insulin resistance
3)Uric acid
4)hs-CRP, TNF-alfa, adiponectin, urinary 8OH-dG
5)Body weight, BMI, body fat parcentage, waist

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are 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 Intake of sudachi peel tablets
(5 tablets/day, for 12 weeks)
Interventions/Control_2 Intake of placebo tablets
(5 tablets/day, 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
20 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria Meets [1) or 2)] and [at least one of the followings;3),4),5)] and 6)
1)Waist>=85cm(man), >=90cm(woman)
2)BMI>=25kg/m/m
3)FBS>=100mg/dl or HbA1c>5.2% or treating wiht the medicine
4)Serum triglyceriders>=150mg/dl or treating wiht the medicine
5)Systolic blood pressure>=130mmHg or diastolic blood pressure>=85mmHg or treating wiht the medicine
6)Is from 20 or more to 74 years old or less
Key exclusion criteria 1)Has complications in brain, heart, kidny, lungs, liver(cerbovascular accident, myocardial infraction, angina pectoris, a history of cardiovascular intervention, heart failure, arteriosclerosis obliterans, nephropathy, bronchial asthma, pulmonary emphysema, pneumenitis, pulmonary fibrosis, viral hepatitis, cirrhosis, diabetic complications, diabetes treated with insulin)
2)To whom pharmaceutical agents shold be considered for hypertension, lipid disorder, diabetes mellitus and/or other diseases
3)Has a overt systemic diseases
4)Has a history of malignant diseases
5)Is a participant in other clinical trial
6)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 Crinical Trial Center for Development Therapeutics
Zip code
Address 2-50-1 Kuramoto-cho, Tokushima
TEL 088-633-9294
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chiho Sato
Organization Tokushima University Hospital
Division name Crinical Trial Center for Development Therapeutics
Zip code
Address 2-50-1 Kuramoto-cho, Tokushima
TEL 088-633-9294
Homepage URL
Email sato-kchm@clin.med.tokushima-u.ac.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization KTT Corporation
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
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 徳島大学病院(徳島県)

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 28 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
2009 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2011 Year 10 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
2009 Year 10 Month 28 Day
Last modified on
2010 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003267

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.