UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on effects of a cereal derived processed product on postprandial energy metabolism.
Title of the study (Brief title)	Study on effects of a cereal derived processed product 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	To investigate effects of a cereal derived processed product on postprandial energy metabolism.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fat oxidation (Measuring time: before ingestion, and every 30 minutes until 4 hours later of the single ingestion of the test diet.)
Key secondary outcomes	Respiratory quotient, thermic effect of food(TEF), i. e., diet-induced thermogenesis(DIT), energy expenditure, and carbohydrate oxidation (Measuring time: before ingestion, and every 30 minutes until 4 hours later of the single ingestion of the test diet.)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Single ingestion of the test diet "X" > Wash out more than 3days > Single ingestion of the test diet "Y" > Wash out more than 3days > Single ingestion of the test diet "Z" (The control meal(code name;C-1),the test meal 1(code name;A-1), and the test meal 2 (code name;A-2). were assigned randomly to "X", "Y", and "Z" by the person in charge.)
Interventions/Control_2	Single ingestion of the test diet "Y" > Wash out more than 3days > Single ingestion of the test diet "Z" > Wash out more than 3days > Single ingestion of the test diet "X" (The control meal(code name;C-1),the test meal 1(code name;A-1), and the test meal 2 (code name;A-2). were assigned randomly to "X", "Y", and "Z" by the person in charge.)
Interventions/Control_3	Single ingestion of the test diet "Z" > Wash out more than 3days > Single ingestion of the test diet "X" > Wash out more than 3days > Single ingestion of the test diet "Y" (The control meal(code name;C-1),the test meal 1(code name;A-1), and the test meal 2 (code name;A-2). were assigned randomly to "X", "Y", and "Z" by the person in charge.)
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	25 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Aged between 24 and 59. 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)Allergy against test food. 5)Person who can't accept to be accessed their medical records. 6)Person who can't answer a questionnaire about life situation and physical condition. 7)Person who are expecting pregnancy or lactation period. 8)Person who can't accept to disclose menstrual cycle. 9)Person who are considered inappropriate by the investigator, project leader, or medical doctors.
Target sample size	50

Research contact person
Name of lead principal investigator	Noriyasu Oota
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	oota.noriyasu@kao.co.jp

Public contact
Name of contact person	Junko Suzuki
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	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)

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	花王株式会社生物科学研究所（栃木県）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 24 Day
Anticipated trial start date	2016 Year 09 Month 05 Day
Last follow-up date	2017 Year 04 Month 06 Day
Date of closure to data entry	2017 Year 05 Month 15 Day
Date trial data considered complete	2017 Year 05 Month 15 Day
Date analysis concluded	2017 Year 06 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	We clarified efficacy of the cereal derived processed products on post prandial fat oxidation.
Other related information

Management information
Registered date	2016 Year 08 Month 26 Day
Last modified on	2017 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027394