UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027514 |
|---|---|
| Receipt number | R000031540 |
| Scientific Title | The effect of DHE on the resting metabolic rate |
| Date of disclosure of the study information | 2017/05/29 |
| Last modified on | 2018/04/13 11:02:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of DHE on the resting metabolic rate
Acronym
DHA and metabolism
Scientific Title
The effect of DHE on the resting metabolic rate
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masanori Ohta |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences
Zip code
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka
TEL
092-661-2411
m-ohta@fwu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Ohta |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences
Zip code
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka
TEL
092-661-2411
Homepage URL
m-ohta@fwu.ac.jp
Sponsor or person
Institute
Fukuoka Women's University
Institute
Department
Personal name
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)
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
| 2017 | Year | 05 | Month | 29 | 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
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.
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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031540
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
