UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036509
Receipt number R000041593
Scientific Title Effect of well-balanced diet on postprandial blood components
Date of disclosure of the study information 2019/04/15
Last modified on 2019/04/15 09:26:29

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Basic information

Public title

Effect of well-balanced diet on postprandial blood components

Acronym

Effect of well-balanced diet on postprandial blood components

Scientific Title

Effect of well-balanced diet on postprandial blood components

Scientific Title:Acronym

Effect of well-balanced diet on postprandial blood components

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to examine the comparative effects of an unbalanced diet (control diet) and a well-balanced diet on postprandial blood components.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood hormone concentration

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking

YES

Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Single ingestion of well-balanced diet.(approximately 630 kcal/meal)->Washout more than 6days ->Single ingestion of control diet.(approximately 630 kcal/meal)->Washout more than 6days ->
Single ingestion of well-balanced diet.(approximately 840 kcal/meal)->Washout more than 6days ->Single ingestion of control diet.(approximately 840 kcal/meal)
-Test for one of five types of meals

Interventions/Control_2

Single ingestion of well-balanced diet.(approximately 630 kcal/meal)->Washout more than 6days ->Single ingestion of control diet.(approximately 630 kcal/meal)->Washout more than 6days ->
Single ingestion of control diet.(approximately 840 kcal/meal)->Washout more than 6days ->Single ingestion of well-balanced diet.(approximately 840 kcal/meal)
-Test for one of five types of meals

Interventions/Control_3

Single ingestion of control diet.(approximately 630 kcal/meal)->Washout more than 6days ->Single ingestion of well-balanced diet.(approximately 630 kcal/meal)->Washout more than 6days ->
Single ingestion of well-balanced diet.(approximately 840 kcal/meal)->Washout more than 6days ->Single ingestion of control diet.(approximately 840 kcal/meal)
-Test for one of five types of meals

Interventions/Control_4

Single ingestion of control diet.(approximately 630 kcal/meal)->Washout more than 6days ->Single ingestion of well-balanced diet.(approximately 630 kcal/meal)->Washout more than 6days ->
Single ingestion of control diet.(approximately 840 kcal/meal)->Washout more than 6days ->Single ingestion of well-balanced diet.(approximately 840 kcal/meal)
-Test for one of five types of meals

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

59 years-old >=

Gender

Male

Key inclusion criteria

1) Subjects who are Japanese male.
Age >=20 and <=59 years.
2) Informed consent provided
3) Able to follow the instructions of the study team

Key exclusion criteria

1) Serious disorder
2) Deconditioning
3) Food allergy and suspected food allergy (Self-reported)
4)Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Shimotoyodome

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

321-3497

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

0285-68-7303

Email

shimotoyodome.akira@kao.com


Public contact

Name of contact person

1st name Junko
Middle name
Last name Suzuki

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

321-3497

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

0285-68-7303

Homepage URL


Email

suzuki.junko1@kao.com


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

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

Human Research Ethics Committee, Kao Corporation

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

Tel

+81-3-5630-9220

Email

uesaka.toshio@kao.com


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

花王株式会社(栃木県)


Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 15 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

25

Results

none

Results date posted

2019 Year 04 Month 15 Day

Results Delayed

Delay expected

Results Delay Reason

Under consideration

Date of the first journal publication of results


Baseline Characteristics

1) Subjects who are Japanese male.
Age >=20 and <=59 years.
2) Informed consent provided
3) Able to follow the instructions of the study team

Participant flow

Recruitment->I.C.->Test

Adverse events

none

Outcome measures

Blood hormone concentration

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 10 Month 01 Day

Date of IRB

2014 Year 10 Month 01 Day

Anticipated trial start date

2014 Year 10 Month 07 Day

Last follow-up date

2014 Year 12 Month 12 Day

Date of closure to data entry

2015 Year 01 Month 28 Day

Date trial data considered complete

2015 Year 01 Month 28 Day

Date analysis concluded

2015 Year 06 Month 29 Day


Other

Other related information



Management information

Registered date

2019 Year 04 Month 15 Day

Last modified on

2019 Year 04 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041593


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name