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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019209
Receipt No. R000022208
Scientific Title Effect of well-balanced diet on postprandial energy metabolism. -Analysis of meal sequence effect-
Date of disclosure of the study information 2015/10/02
Last modified on 2016/03/04

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Basic information
Public title Effect of well-balanced diet on postprandial energy metabolism.
-Analysis of meal sequence effect-
Acronym Effect of well-balanced diet on postprandial energy metabolism
Scientific Title Effect of well-balanced diet on postprandial energy metabolism.
-Analysis of meal sequence effect-
Scientific Title:Acronym Effect of well-balanced diet on postprandial energy metabolism
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 and a well-balanced diet on postprandial energy metbolism in healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Thermic effect of food (TEF), i. e., diet-induced thermogenesis (DIT), energy expenditure, substrate oxidation, respiratory quotient until 6 hours later of the meal.
Key secondary outcomes Body temperature until 6 hours later of the meal.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 First ingestion of a test meal (approximately 630 kcal/meal), following second ingestion of a test meal (approximately 630 kcal/meal) after 4 hours of first ingestion.
First meal: unbalanced diet. Second meal: unbalanced diet.
Interventions/Control_2 First ingestion of a test meal (approximately 630 kcal/meal), following second ingestion of a test meal (approximately 630 kcal/meal) after 4 hours of first ingestion.
First meal: well-balanced diet. Second meal: unbalanced diet.
Interventions/Control_3 First ingestion of a test meal (approximately 630 kcal/meal), following second ingestion of a test meal (approximately 630 kcal/meal) after 4 hours of first ingestion.
First meal: unbalanced diet. Second meal: well-balanced diet.
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)Japanese male Age >=20 and <=59 years.
2)Body mass index >=18.5 kg/m2 and <25 kg/m2
3)Fasting blood glucose value <126 mg/dL
4)Fasting triglyceride value >=50 and <=149 mg/dL
5)Systolic blood pressure <=139 mmHg and diastolic blood pressure <=89 mmHg
6)Informed consent provided
7)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 Akira Shimotoyodome
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 0285-68-7589
Email shimotoyodome.akira@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junko Suzuki
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 suzuki.junko1@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生理機能棟(栃木県)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 02 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
2015 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 07 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
2015 Year 10 Month 02 Day
Last modified on
2016 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022208

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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