UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044701
Receipt number R000051054
Scientific Title Food quotient of young people obtained from dietary record
Date of disclosure of the study information 2021/06/29
Last modified on 2021/06/29 14:07:49

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Basic information

Public title

Food quotient of young people obtained from dietary record

Acronym

Food quotient of young people obtained from dietary record

Scientific Title

Food quotient of young people obtained from dietary record

Scientific Title:Acronym

Food quotient of young people obtained from dietary record

Region

Japan


Condition

Condition

Generally healthy participants

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to clarify the food quotient of young people obtained from dietary records.

Basic objectives2

Others

Basic objectives -Others

The second aim is to clarify the validation of the methodology calculated using the food frequency questionnaire.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Food quotient

Key secondary outcomes

1)Energy intake
2)Carbohydrate intake
3)Fat intake
4)Protein intake


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit

39 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Healthy individuals aged over 18 years old
2) Individuals have not been restricted the exercise

Key exclusion criteria

1)Current medical conditions
2)Metabolic disorders
3)Smokers

Target sample size

49


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Sagayama

Organization

University of Tsukuba

Division name

Faculty of Health and Sport Sciences

Zip code

305-8574

Address

1-1-1 Tennodai, Tsukuba, Ibaraki, Japan

TEL

+81-29-853-3963

Email

sagayama.hiroyuki.ka@u.tsukuba.ac.jp


Public contact

Name of contact person

1st name Akiko
Middle name
Last name Uchizawa

Organization

University of Tsukuba

Division name

Doctorial program in Sports Medicine

Zip code

305-8574

Address

1-1-1 Tennodai, Tsukuba, Ibaraki, Japan

TEL

+81-29-853-3963

Homepage URL


Email

aaa.agt.221@gmail.com


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

University of Tsukuba

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Tsukuba, Faculty of Health and Sport Sciences IRB

Address

1-1-1 Tennodai, Tsukuba, Ibaraki, Japan

Tel

+81-29-853-2571

Email

hitorinri@un.tsukuba.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



Other administrative information

Date of disclosure of the study information

2021 Year 06 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

49

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

Completed

Date of protocol fixation

2017 Year 10 Month 01 Day

Date of IRB

2019 Year 08 Month 02 Day

Anticipated trial start date

2019 Year 09 Month 01 Day

Last follow-up date

2021 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

No


Management information

Registered date

2021 Year 06 Month 29 Day

Last modified on

2021 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051054


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name