UMIN-CTR Clinical Trial

Basic information
Public title	Dietary balance and skeletal muscle mass.
Acronym	Dietary balance and skeletal muscle mass.
Scientific Title	A cross-sectional study to clarifying whether low protein intake and breakfast skipping affect skeletal muscle mass.
Scientific Title:Acronym	A cross-sectional study to clarifying whether low protein intake and breakfast skipping affect skeletal muscle mass.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Cross-sectional survey of workers' skeletal muscle mass, bone density, dietary intake, three major nutrient ratios, daily physical activity, weekly exercise time, and health literacy on diet and exercise habits in order to investigate the relation with skeletal muscle mass and other factors.
Basic objectives2	Others
Basic objectives -Others	Does skipping breakfast affect skeletal muscle?
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between protein intake and skeletal muscle mass.
Key secondary outcomes	Relationship between breakfast skipping and skeletal muscle mass

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	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	Male and female workers between the ages of 20 and 60 years-old.
Key exclusion criteria	1)Heart pacemaker wearer. 2)Pregnant and nursing. 3)Continuous muscle training for at least three months. 4)Those who take protein continuously. 5)Professional athlete, bodybuilder.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Natsuko Middle name Last name Yoshimochi
Organization	Japan Organization of Occupational Health and Safety Osaka Rosai Hospital
Division name	Research Center for the Promotion of Health and Employment Support
Zip code	591-8025
Address	1179-3, Nagasone-cho, Kita-ku, Sakai-City, Osaka.
TEL	072-252-3561
Email	n.yoshimochi@osakah.johas.go.jp

Public contact
Name of contact person	1st name Natsuko Middle name Last name Yoshimochi
Organization	Japan Organization of Occupational Health and Safety Osaka Rosai Hospital
Division name	Research Center for the Promotion of Health and Employment Support
Zip code	591-8025
Address	1179-3, Nagasone-cho, Kita-ku, Sakai-City, Osaka.
TEL	072-252-3561
Homepage URL
Email	n.yoshimochi@osakah.johas.go.jp

Sponsor
Institute	Japan Organization of Occupational Health and Safety Osaka Rosai Hospital
Institute
Department

Funding Source
Organization	Japan Organization of Occupational Health and Safety
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	Japan Organization of Occupational Health and Safety Osaka Rosai Hospital
Address	1179-3, Nagasone-cho, Kita-ku, Sakai-city, Osaka
Tel	072-252-3561
Email	n.yoshimochi@osakah.johas.go.jp

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	2020 Year 04 Month 01 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	100
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	No longer recruiting
Date of protocol fixation	2020 Year 01 Month 07 Day
Date of IRB	2020 Year 02 Month 03 Day
Anticipated trial start date	2020 Year 04 Month 15 Day
Last follow-up date	2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	NO

Management information
Registered date	2020 Year 03 Month 24 Day
Last modified on	2022 Year 03 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045356