UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impacts of energy intake and nutritional characteristics on body composition in patients with pulmonary nontuberculous mycobacterial disease
Title of the study (Brief title)	Impact of nutritional characteristics in patients with pulmonary nontuberculous mycobacterial disease
Region	Japan

Condition
Condition	Pulmonary nontuberculous mycobacterial disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the impacts of energy intake and nutritional characteristics on body composition and respiratory muscle strength in patients with pulmonary nontuberculous mycobacterial disease.
Basic objectives2	Others
Basic objectives -Others	Energy intake and body composition
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Energy intake
Key secondary outcomes	Energy and nutrient intakes Nutritional biomarkers Body composition Physical functions (grip strength and gait speed) Pulmonary function Respiratory muscle strength Psychological parameters (appetite, depression, anxiety, and body image) Frailty Life style (eating habits, exercise habits, physical activity)

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Meet the followings: 1) The patients visiting Respiratory Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute. 2) The patients diagnosed as pulmonary nontuberculous mycobacterial disease by 2007 American Thoracic society guidelines.
Key exclusion criteria	Fall under any of the followings: 1) Under 20 years old 2) Patients who were unable to obtain informed consent 3) Patients diagnosed as dementia or psychiatric disorders by their attending physician 4) Patients diagnosed as ineligible patient for other reasons by their attending physician
Target sample size	100

Research contact person
Name of lead principal investigator	Yumi Takayama
Organization	Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division name	Nutrition department
Address	2-4-20 Ogimachi, Kita-ku, Osaka-shi, Osaka
TEL	06-6131-1221
Email	hinatabokko0401@yahoo.co.jp

Public contact
Name of contact person	Yumi Takayama
Organization	Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division name	Department of Nutrition
Address	2-4-20 Ogimachi, Kita-ku, Osaka-shi, Osaka
TEL	06-6131-1221
Homepage URL
Email	hinatabokko0401@yahoo.co.jp

Sponsor
Institute	Kitano Hospital, Tazuke Kofukai Medical Research Institute
Institute
Department

Funding Source
Organization	Kitano Hospital, Tazuke Kofukai Medical Research Institute
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	田附興風会医学研究所北野病院(大阪府)

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 01 Day
Anticipated trial start date	2018 Year 07 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 impacts of energy intake and nutritional characteristics on body composition and respiratory muscle strength in patients with pulmonary nontuberculous mycobacterial disease.

Management information
Registered date	2018 Year 08 Month 08 Day
Last modified on	2019 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038409