UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035207
Receipt number R000040118
Scientific Title The intervention study of the improvement between health and breakfast consumption using cereal food.
Date of disclosure of the study information 2018/12/20
Last modified on 2019/12/11 18:32:49

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Basic information

Public title

The intervention study of the improvement between health and breakfast consumption using cereal food.

Acronym

The intervention study of the improvement between health and breakfast consumption using cereal food.

Scientific Title

The intervention study of the improvement between health and breakfast consumption using cereal food.

Scientific Title:Acronym

The intervention study of the improvement between health and breakfast consumption using cereal food.

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this intervention study is the improvement between health and breakfast consumption using cereal food in breakfast.

Basic objectives2

Others

Basic objectives -Others

We aim at the construction of new evidence about the establishment of the breakfast intake custom.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

We analyze health, nutrient intake per day, and physical activity level per day.

Key secondary outcomes

Not applicable


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Taking a cereal food with milk or yogurt in breakfast for two weeks

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Not having the custom of breakfast consumption

Key exclusion criteria

Person with allergy and under th treatment

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kazuo
Middle name
Last name Minematsu

Organization

Nagasaki University

Division name

Graduate School of Education

Zip code

8528521

Address

1-14, Bunkyo-machi, Nagasaki

TEL

095-819-2359

Email

minematsu@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Kazuo
Middle name
Last name Minematsu

Organization

Nagasaki University

Division name

Graduate School of Education

Zip code

8528521

Address

1-14, Bunkyo-machi, Nagasaki

TEL

095-819-2359

Homepage URL


Email

minematsu@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Calbee Inc

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

Graduate School of Biomedical Sciences, Nagasaki University

Address

1-12-4, Sakamoto, Nagasaki

Tel

095-819-7198

Email

yoshi-t@nagasaki-u.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

2018 Year 12 Month 20 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

Completed

Date of protocol fixation

2018 Year 10 Month 10 Day

Date of IRB

2018 Year 11 Month 05 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2019 Year 02 Month 28 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 12 Month 10 Day

Last modified on

2019 Year 12 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040118


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name