UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of well-balanced diet on postprandial energy metabolism.(Comparison with control diet have a similar menu construction)
Title of the study (Brief title)	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 compare the effects of well-balanced diet with control diet that have similar menu construction on postprandial energy metabolism in healthy adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Energy expenditure, substrate oxidation, respiratory quotient of 0.5, 1,1.5, 2, 3, 4 hours after single ingestion of well-balanced diet or control diet.
Key secondary outcomes	Body temperature of 0.5, 1, 1.5, 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/mea) -> 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	20

Research contact person
Name of lead principal investigator	Noriyasu Ota
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
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	Chika Suzukamo
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
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)

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	2016 Year 06 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 14 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 15 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=R000026210