UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045051 |
|---|---|
| Receipt number | R000051462 |
| Scientific Title | Effects of long-term intake of omega-3 fatty acids on energy metabolism and biological rhythms |
| Date of disclosure of the study information | 2021/08/10 |
| Last modified on | 2021/08/03 12:19:03 |
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Basic information
Public title
Effects of long-term intake of omega-3 fatty acids on energy metabolism and biological rhythms
Acronym
Effects of long-term intake of omega-3 fatty acids on energy metabolism and biological rhythms
Scientific Title
Effects of long-term intake of omega-3 fatty acids on energy metabolism and biological rhythms
Scientific Title:Acronym
Effects of long-term intake of omega-3 fatty acids on energy metabolism and biological rhythms
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of a 12-week intake of 1.5-2.0 g of omega-3 fatty acids on energy metabolism and sleep status in healthy men and women without sleep disturbances.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
To evaluate the energy metabolism in human calorimeter, 12 weeks continuously intake of omega-3 fatty acid 1.5-2.0mg.
Key secondary outcomes
To evaluate the quality of sleep in human calorimeter, 12 weeks continuously intake of omega-3 fatty acid 1.5-2.0mg. Blood and urine samples will be collected and metabolite measurements will be performed to assess energy metabolism status.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects will be given a 12-week intervention in which they will consume foods containing 1.5-2.0 mg of omega-3 fatty acids. In addition to the energy metabolism measurements, the intervention will include three blood and six urine collections in a 24-hour period.
Interventions/Control_2
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Good sleeper and healthy male or female.
2) Body mass index (BMI) is more than 18.5 and less than 30.
3) Age is more than 18 and less than 59 years old.
Key exclusion criteria
1) Change body weight plus or minus 2.0kg before a month.
2) Pregnant.
3) Severe problem in the menstrual cycle.
4) Engaged in regular exercise more than twice a week.
5) Use any regular or temporary medication.
6) Smokers.
7) Drinking more than a bottle of alcohol (350 ml) per day.
8) clinical diagnosis (apnea sleep hypopnea) or medical/psychiatric condition.
9) shift workers.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Yajima |
Organization
Josai University
Division name
Pharmaceutical Sciences
Zip code
350-0295
Address
1-1 Keyakidai, Sakado, Saitama, JAPAN
TEL
049-271-8015
k-yajima@josai.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Yajima |
Organization
Josai University
Division name
Pharmaceutical Sciences
Zip code
350-0295
Address
1-1 Keyakidai, Sakado, Saitama, JAPAN
TEL
049-271-8015
Homepage URL
k-yajima@josai.ac.jp
Sponsor or person
Institute
Pharmaceutical Sciences, Josai University
Institute
Department
Personal name
Funding Source
Organization
MIYOSHI OIL & FAT CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Josai University
Address
1-1 Keyakidai, Sakado, Saitama, JAPAN
Tel
049-271-8015
k-yajima@josai.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2019-11A
Org. issuing International ID_1
Josai University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
城西大学（埼玉県）、富士医科産業株式会社（千葉県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 03 | Day |
Last modified on
| 2021 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051462
