UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of breakfast consumption and exercise on cognitive function
Title of the study (Brief title)	Effects of breakfast consumption and exercise on cognitive function
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the interactive effects of breakfast and exercise on cognitive function
Basic objectives2	Others
Basic objectives -Others	Exploratory study
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive tasks to assess working memory [Spatial Delayed Response (DR) task] and executive function [Go/No-Go (GNG) task] at rest, during exercise and after exercise in the breakfast consumption or omission conditions
Key secondary outcomes	1.Blood glucose, insulin and lactate concentration and heart rate at rest, during exercise and after exercise in the breakfast consumption or omission conditions 2.Total carbohydrate and fat oxidation during exercise in the breakfast consumption or omission conditions 3.Two-dimensional Mood Scale-Short Term at rest and after exercise in the breakfast consumption or omission conditions

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	They exercise for 30 min at 50% VO2peak three times more than three days apart in the following breakfast conditions in the following order; carbohydrate diet consumption, placebo diet consumption and breakfast omission
Interventions/Control_2	They exercise for 30 min at 50% VO2peak three times more than three days apart in the following breakfast conditions in the following order; carbohydrate diet consumption, breakfast omission and placebo diet consumption
Interventions/Control_3	They exercise for 30 min at 50% VO2peak three times more than three days apart in the following breakfast conditions in the following order; placebo diet consumption, breakfast omission and carbohydrate diet consumption
Interventions/Control_4	They exercise for 30 min at 50% VO2peak three times more than three days apart in the following breakfast conditions in the following order; placebo diet consumption, carbohydrate diet consumption and breakfast omission
Interventions/Control_5	They exercise for 30 min at 50% VO2peak three times more than three days apart in the following breakfast conditions in the following order; breakfast omission, carbohydrate diet consumption and placebo diet consumption
Interventions/Control_6	They exercise for 30 min at 50% VO2peak three times more than three days apart in the following breakfast conditions in the following order; breakfast omission, placebo diet consumption and carbohydrate diet consumption
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male
Key inclusion criteria	Healthy men not less than 20 years old and under 40 years old
Key exclusion criteria	1) Seriously or progressive ill patients 2) Smoker 3) Alcoholics 4) Subjects who participated with other clinical study within 1 month before screening of this study 5) Subjects who are diagnosed as abnormal condition by doctor 6) Subjects who are judged as unsuitable for this study by the research contact person for other reason
Target sample size	12

Research contact person
Name of lead principal investigator	Yasuki Higaki
Organization	Fukuoka University
Division name	Faculty of Sports and Health Science
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL	+81-92-871-6631
Email	higaki@fukuoka-u.ac.jp

Public contact
Name of contact person	Takaaki Komiyama
Organization	Fukuoka University
Division name	Faculty of Sports and Health Science
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL	+81-92-871-6631
Homepage URL
Email	mt.komi51@gmail.com

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	Fukuoka University
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 20 Day
Anticipated trial start date	2016 Year 03 Month 07 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 03 Month 06 Day
Last modified on	2017 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024634