UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of relevance between food behavior and physical activity in Japanese elderly people: a cross-sectional study
Title of the study (Brief title)	Verification of relevance between food behavior and physical activity in Japanese elderly people
Region	Japan

Condition
Condition	Normal
Classification by specialty	Endocrinology and Metabolism Geriatrics Psychiatry Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relevance between food behavior and physical activity in Japanese elderly people
Basic objectives2	Others
Basic objectives -Others	A cross-sectional study
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relevancies among a diet survey, physical activity/performance, a cognitional function and blood metabolites/hormones concentrations
Key secondary outcomes	Relevancies between various questionnaires and a diet survey, physical activity/performance, a cognitional function or blood metabolites/hormones concentrations. Relevancies between body compositions and a diet survey, physical activity/performance, a cognitional function or blood metabolites/hormones concentrations

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	65 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	. 65-75 years old men and women who can attend an examination hall . Subjects who can take photographs with a disposable camera about all meals for three days in daily life . Subjects who can carry two kinds of accelerometers for one week in daily life . Subjects who can follow directions of medical workers in this clinical study
Key exclusion criteria	. Subjects who are not eligible due to physician's judgment
Target sample size	500

Research contact person
Name of lead principal investigator	Masashi Miyashita
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15, Mikajima, Tokorozawa, Saitama, Japan
TEL	+81-429-47-6774
Email	m.miyashita@waseda.jp

Public contact
Name of contact person	Masashi Miyashita
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15, Mikajima, Tokorozawa, Saitama, Japan
TEL	+81-429-47-6774
Homepage URL
Email	m.miyashita@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	818-20161118
Org. issuing International ID_1	Kao Corporation
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	早稲田大学所沢（埼玉県）および東伏見（東京都）キャンパス

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 26 Day
Anticipated trial start date	2017 Year 02 Month 23 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	To investigate the relevance between food behavior and physical activity in Japanese elderly people

Management information
Registered date	2017 Year 02 Month 06 Day
Last modified on	2018 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029859