UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021366 |
|---|---|
| Receipt number | R000024634 |
| Scientific Title | Effects of breakfast consumption and exercise on cognitive function |
| Date of disclosure of the study information | 2016/03/06 |
| Last modified on | 2017/03/07 10:14:49 |
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Basic information
Public title
Effects of breakfast consumption and exercise on cognitive function
Acronym
Effects of breakfast consumption and exercise on cognitive function
Scientific Title
Effects of breakfast consumption and exercise on cognitive function
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yasuki Higaki |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
+81-92-871-6631
higaki@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Komiyama |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
+81-92-871-6631
Homepage URL
mt.komi51@gmail.com
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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 | 02 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024634
