UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluate the effects of an oral fat load containing coconut oil on the postprandial ketone-body responses.:randomized, single-blind, controlled, crossover trial
Title of the study (Brief title)	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	Terue Kawabata
Organization	Kagawa nutrition university
Division name	Basic nutrition
Address	3-9-21 Chiyoda Sakado Saitama
TEL	049-282-3705
Email	kawabata@eiyo.ac.jp

Public contact
Name of contact person	Yuka Furuta
Organization	Graduate school of Kagawa nutrition university
Division name	Basic nutrition
Address	3-9-21 Chiyoda Sakado Saitama
TEL	049-282-3705
Homepage URL
Email	fya151@eiyo.ac.jp

Sponsor
Institute	Kagawa nutrition university
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023043