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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036509
Receipt No. 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

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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
Institute Kao Corporation
Institute
Department

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
URL(English) https://upload.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


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