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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021609
Receipt No. R000024924
Scientific Title Effect of well-balanced diet on postprandial blood components. (Comparison with control diet have a similar menu construction)
Date of disclosure of the study information 2016/03/25
Last modified on 2016/12/19

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Basic information
Public title Effect of well-balanced diet on postprandial blood components.
(Comparison with control diet have a similar menu construction)
Acronym Effect of well-balanced diet on postprandial blood components.
Scientific Title Effect of well-balanced diet on postprandial blood components.
(Comparison with control diet have a similar menu construction)
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 compare the effects of well-balanced diet with control diet that have similar menu construction on postprandial blood components healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood hormone concentration of 0.5, 1, 2, 3, 4 hours after single ingestion of well-balanced diet or control diet
Key secondary outcomes Blood glucose, TG, NEFA concentrations of 0.5, 1, 2, 3, 4 hours after single ingestion of well-balanced diet or control diet

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
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Single ingestion of well-balanced diet.(approximately 650 kcal/meal) -> Washout more than 5days -> Single ingestion of control diet.(approximately 650 kcal/meal)
Interventions/Control_2 Single ingestion of control diet.(approximately 650 kcal/meal) -> Washout more than 5days -> Single ingestion of well-balanced diet.(approximately 650 kcal/meal)
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
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) Regular hospital visit and medication intended to cure
3) Daily excessive alcohol intake
(Amount of alcohol intake >= 23 g/day)
4) Food allergy and suspected food allergy (Self-reported)
5)Subjects judged by the investigator/project leader to be ineligible for other reasons
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyasu Ota
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7828
Email ota.noriyasu@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chika Suzukamo
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7687
Homepage URL
Email suzukamo.chika@kao.co.jp

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
Address
Tel
Email

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 花王株式会社栃木事業場(栃木)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 25 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
2016 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 25 Day
Last modified on
2016 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024924

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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