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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010633
Receipt No. R000012433
Scientific Title Effects of Sudachi peels on prevention and improvement of metabolic syndrome
Date of disclosure of the study information 2013/05/01
Last modified on 2017/01/19

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Basic information
Public title Effects of Sudachi peels on prevention and improvement of metabolic syndrome
Acronym Anti-obesity effects of Sudachi peels
Scientific Title Effects of Sudachi peels on prevention and improvement of metabolic syndrome
Scientific Title:Acronym Anti-obesity effects of Sudachi peels
Region
Japan

Condition
Condition overweight or patinets with high triglycerode
healthy people
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine that Sudachi peels are effective on prevention or improvement of metabolic syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes body weight, serum TG, fasting blood glucose, glucose tolerance
Key secondary outcomes

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 Treatment
Type of intervention
Food
Interventions/Control_1 intervension; take Sudachi peels supplements
Interventions/Control_2 Control; take placebo supplements
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
60 years-old >
Gender Male
Key inclusion criteria overweight (>BMI25)
hypertriglyceridemia (>150mg/dL)
Key exclusion criteria patients with metabolic disease including diabetes, liver disease or renal disease
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Sakai
Organization University of Tokushima
Division name Nutrition
Zip code
Address 3-18-15 Kuramoto, Tokushima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Rie Tsutsumi
Organization University of Tokushima
Division name Nutrition
Zip code
Address
TEL 81-88-633-7450
Homepage URL
Email

Sponsor
Institute University of Tokushima
Institute
Department

Funding Source
Organization Cluster brochure
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
2013 Year 05 Month 01 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
2013 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 01 Day
Last modified on
2017 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012433

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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