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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name