UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of meal freaquency for weight gain program in athletes
Title of the study (Brief title)	Examination of meal freaquency for weight gain program in athletes
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect for weight gain by different meal freaquency with positive energy intake of additional>16~18kcal/kg BW than total energy expenditure as well as fat energy ratio of less than 30%.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body composition
Key secondary outcomes	Body weight Blood biochemical parameter

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food Other
Interventions/Control_1	Intervention priod:8 weeks Meal freaquency: three times per day Energy intalke:additional>1000kcal (appropriayely>18kcal/kgBW) energy of meals on the total energy expenditure Fat ratio of energy intake:less than 30%
Interventions/Control_2	ntervention priod:8 weeks Meal freaquency: six times per day Energy intalke:additional>1000kcal (appropriayely>18kcal/kgBW) energy of meals on the total energy expenditure Fat ratio of energy intake:less than 30%
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	18 years-old <=
Age-upper limit	23 years-old >=
Gender	Male
Key inclusion criteria	Collegiate athletes required weight gain
Key exclusion criteria	With gastrointestinal symptom With gastrointestinal disease
Target sample size	15

Research contact person
Name of lead principal investigator	Motoko Taguchi
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa, Saitama
TEL	04-2947-6778
Email	mtaguchi@waseda.jp

Public contact
Name of contact person	Hiroko Murata
Organization	Waseda University
Division name	Organization for University Reserch Initiative
Address	2-579-15 Mikajima, Tokorozawa, Saitama
TEL	04-2947-6778
Homepage URL
Email	hmurata567@aoni.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Self Funding
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 06 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 26 Day
Anticipated trial start date	2012 Year 01 Month 10 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	2018 Year 06 Month 12 Day
Last modified on	2018 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037578