UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of gene-based exercise and nutrition program for preventing locomotive syndrome
Title of the study (Brief title)	Development of gene-based exercise and nutrition program for preventing locomotive syndrome: GENEFITT trial
Region	Japan Asia(except Japan)

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To develop and investigate the feasibility of gene-based exercise and nutrition program for preventing locomotive syndrome
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fat free mass (Time Frame: change from baseline at 12 weeks)
Key secondary outcomes	1) Anthropometric parameters (weight, body fat) 2) Blood pressure 3) Muscle function (timed up and go test, grip strength) 4) Questionnaire (Osteoarthritis Index, Locomotion Check, Constipation score, Healthy lifestyle behaviors, Satisfaction)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Gene-based exercise and nutrition program during 12 weeks
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	40 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Subjects with 40-69 age 2) Male and Female 3) Provided written consent to participate in this study
Key exclusion criteria	1) Subjects who can't exercise therapy 2) Ongoing participation in other clinical trials or research 3) Subjects who are inappropriate for this study determined by the research team.
Target sample size	30

Research contact person
Name of lead principal investigator	Kawata Shigeji
Organization	Northern Lights Corporation
Division name	Northern Lights Corporation
Address	373-30 Horike-cho, Higashiyama-ku, Kyoto 605-0038, Japan
TEL	+81-75-692-3465
Email	kawata@terrsa-fitness.com

Public contact
Name of contact person	Kawata Shigeji
Organization	Northern Lights Corporation
Division name	Northern Lights Corporation
Address	373-30 Horike-cho, Higashiyama-ku, Kyoto 605-0038, Japan
TEL	+81-75-692-3465
Homepage URL
Email	kawata@terrsa-fitness.com

Sponsor
Institute	Northern Lights Corporation
Institute
Department

Funding Source
Organization	Northern Lights Corporation
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	2017 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 20 Day
Anticipated trial start date	2017 Year 10 Month 01 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	2017 Year 09 Month 26 Day
Last modified on	2018 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033386