UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019959 |
|---|---|
| Receipt number | R000023043 |
| Scientific Title | Evaluate the effects of an oral fat load containing coconut oil on the postprandial ketone-body responses.:randomized, single-blind, controlled, crossover trial |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2016/12/28 15:50:24 |
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Basic information
Public title
Evaluate the effects of an oral fat load containing coconut oil on the postprandial ketone-body responses.:randomized, single-blind, controlled, crossover trial
Acronym
Postprandial ketone-body responses with coconut oil.
Scientific Title
Evaluate the effects of an oral fat load containing coconut oil on the postprandial ketone-body responses.:randomized, single-blind, controlled, crossover trial
Scientific Title:Acronym
Postprandial ketone-body responses with coconut oil.
Region
| Japan |
Condition
Condition
nothing
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the ability of postprandial metabolism of edible oils with different fatty acid composition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Postprandial serum ketone-body responses
Key secondary outcomes
Triacylglycerol
Lipoprotein-Cholesterol
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food(Coconut oil, MCT oil, LCT oil)
Interventions/Control_2
Test food(Coconut oil, MCT oil, LCT oil)
Interventions/Control_3
Test food(Coconut oil, MCT oil, LCT oil)
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
BMI:18.5-25.0
Physical Activity Level1,2
Key exclusion criteria
1)Invalid person
2)Smoker
3)Oil sapriment consumer
4)Pregnancy, nurse and these preparation
5)Systolic blood pressure under 90mmHg
6)Menopausal women
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Terue Kawabata |
Organization
Kagawa nutrition university
Division name
Basic nutrition
Zip code
Address
3-9-21 Chiyoda Sakado Saitama
TEL
049-282-3705
kawabata@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Furuta |
Organization
Graduate school of Kagawa nutrition university
Division name
Basic nutrition
Zip code
Address
3-9-21 Chiyoda Sakado Saitama
TEL
049-282-3705
Homepage URL
fya151@eiyo.ac.jp
Sponsor or person
Institute
Kagawa nutrition university
Institute
Department
Personal name
Funding Source
Organization
Kagawa nutrition university
Organization
Division
Category of Funding Organization
Other
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
女子栄養大学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | 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
| 2015 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | 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
| 2015 | Year | 11 | Month | 27 | Day |
Last modified on
| 2016 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023043
