UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of DHE on the resting metabolic rate
Title of the study (Brief title)	DHA and metabolism
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to elucidate the effect of DHA on the resting metabolic rate.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Resting metabolic rate after 12 weeks
Key secondary outcomes	body composition including muscle volume and fat volume, body temperature, plasma irisin level, oxidative stress, and dietary uptake.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Taking DHA supplement
Interventions/Control_2	Taking plant oil (Japanese basil oil) in the control group.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Those who do not have allergy for DHA and/or plant oil, and those who do not take DHA and/or plant oil on regular basis.
Key exclusion criteria	Those who have allergy for DHA and/or plant oil, and those who take DHA and/or plant oil on regular basis.
Target sample size	30

Research contact person
Name of lead principal investigator	Masanori Ohta
Organization	Fukuoka Women's University
Division name	International College of Arts and Sciences
Address	1-1-1 Kasumigaoka, Higashi-ku, Fukuoka
TEL	092-661-2411
Email	m-ohta@fwu.ac.jp

Public contact
Name of contact person	Masanori Ohta
Organization	Fukuoka Women's University
Division name	International College of Arts and Sciences
Address	1-1-1 Kasumigaoka, Higashi-ku, Fukuoka
TEL	092-661-2411
Homepage URL
Email	m-ohta@fwu.ac.jp

Sponsor
Institute	Fukuoka Women's University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Local Government
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

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 14 Day
Last follow-up date	2017 Year 09 Month 07 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 10 Month 13 Day
Date analysis concluded	2018 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The tympanic temperature was increase in alpha-linoleic acid group, but not in DHA group. The fat mass was significantly decreased in DHA group, but not in alpha-linoleic acid group.
Other related information

Management information
Registered date	2017 Year 05 Month 28 Day
Last modified on	2018 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031540