UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010633 |
|---|---|
| Receipt number | 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 09:24:01 |
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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
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
Sponsor or person
Institute
University of Tokushima
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012433
