UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050707 |
|---|---|
| Receipt number | R000057763 |
| Scientific Title | Effects of meals with different fatty acid composition on metabolic flexibility and blood and urine metabolites |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/03/29 08:47:01 |
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Basic information
Public title
Effects of meals with different fatty acid composition on metabolic flexibility and blood and urine metabolites
Acronym
Effects of meals with different fatty acid composition on metabolic flexibility and blood and urine metabolites
Scientific Title
Effects of meals with different fatty acid composition on metabolic flexibility and blood and urine metabolites
Scientific Title:Acronym
Effects of meals with different fatty acid composition on metabolic flexibility and blood and urine metabolites
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine the effects of different fatty acid intakes on metabolic flexibility
Basic objectives2
Others
Basic objectives -Others
Determine the effects of different fatty acid intakes on plasma and urine metabolites
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Energy metabolism (energy expenditure, respiratory quotient, carbohydrate oxidation, fat oxidation, protein oxidation), blood and urine metabolites (acylcarnitines, TCA cycle intermediates and other energy metabolism related substances)
Key secondary outcomes
Serum free fatty acids, hormone secretion, EEG during sleep, blood pressure, body temperature, heart rate, autonomic nervous activity, gene expression in leukocytes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake a diet rich in long chain saturated fatty acids
Interventions/Control_2
Intake a diet rich in monounsaturated fatty acids
Interventions/Control_3
Intake a diet rich in polyunsaturated fatty acids
Interventions/Control_4
Intake a diet rich in middle chain saturated fatty acids
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
No health problems
No sleep problems
Key exclusion criteria
Smokers
Shift Workers
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Yajima |
Organization
Josai university
Division name
Faculty of Pharmacy
Zip code
3500295
Address
Keyakidai 1-1, Sakado City, Saitama Prefecture
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
Faculty of Pharmacy
Zip code
350-0295
Address
Keyakidai 1-1, Sakado City, Saitama Prefecture
TEL
049-271-8015
Homepage URL
k-yajima@josai.ac.jp
Sponsor or person
Institute
Josai university
Institute
Department
Personal name
Funding Source
Organization
Josai 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
Josai unibversity
Address
Keyakidai 1-1, Sakado City, Saitama Prefecture
Tel
049-271-8015
k-yajima@josai.ac.jp
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
城西大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 03 | Month | 29 | Day |
Last modified on
| 2023 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057763
