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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013142
Receipt No. R000015322
Scientific Title The effect of macadamia oil on improving insulin sensitivity
Date of disclosure of the study information 2014/02/12
Last modified on 2014/02/12

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Basic information
Public title The effect of macadamia oil on improving insulin sensitivity
Acronym The effect of macadamia oil on improving insulin sensitivity
Scientific Title The effect of macadamia oil on improving insulin sensitivity
Scientific Title:Acronym The effect of macadamia oil on improving insulin sensitivity
Region
Japan

Condition
Condition metabolic syndrome
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examines the percutaneous absorption abilities and glucose metabolism of macadamia nut oil with healthy volunteers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Key secondary outcomes Changes in blood fatty acid content
Serum adiponectin concentration
Glucose metabolic function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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
Other
Interventions/Control_1 Macadamia nut oil
Interventions/Control_2 Coconut oil
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patient who have metabolic syndrome or BMI 25<, obesity
2) Patients who are obtained with the prior written consent.
Key exclusion criteria 1) Patient who have a history of allergic disease.
2) Patient who had an allergic reaction in the patch test.
3) Patient who has the possibility of pregnancy, pregnancy.
4) People who have cognitive disorder (delirium, dementia and so on), schizophrenia or bipolar disorder.
5) Patients judged to be inappropriate for this study from the doctor in charge.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Ito
Organization Osaka University Graduate School of Medicine
Division name Department of Complementary and Alternative Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3498
Email juki@cam.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miki Sakaue
Organization Osaka University Graduate School of Medicine
Division name Department of Complementary and Alternative Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3498
Homepage URL
Email mikity@cam.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Department of Complementary and Alternative Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
Department of Complementary and Alternative Medicine
Organization
Division
Category of Funding Organization Self funding
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 大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 12 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
2011 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 10 Day
Last follow-up date
2013 Year 11 Month 09 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 02 Month 12 Day
Last modified on
2014 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015322

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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