臨床研究等提出・公開システム

Scientific Title	Prognostic Implications of Changes in Ghrelin Concentrations in Amyotrophic Lateral Sclerosis
Public Title	Changes in Ghrelin Concentrations in Amyotrophic Lateral Sclerosis

Contact for Scientific Queries	Name	Matsushita Takuya
	Affiliation	Kochi Medical School
	Address	185-1 Kohasu,Oko-cho,Nankoku-shi,Kochi
	Telephone	+81-88-888-2749
	E-mail	matsushita_takuya@kochi-u.ac.jp
Contact for Public Queries	Name	Hashimoto Yu
	Affiliation	Kochi Medical School
	Address	185-1 Kohasu,Oko-cho,Nankoku-shi,Kochi
	Telephone	+81-88-888-2749
	E-mail	hashimotoyu@kochi-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 06, 2026
Actual date of first enrollment		June. 30, 2026
Target sample size		60
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	The study will include patients aged 18 years or older who have been diagnosed with ALS using the Gold Coast diagnostic criteria. The study will include ALS patients within two years of onset. As healthy controls, the study will include adults who have similar lifestyle backgrounds, do not have ALS, and are not related to the patient by blood.
	Exclusion Criteria	As healthy controls, individuals with a BMI of 25 or higher were excluded.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Amyotrophic Lateral Sclerosis
Intervention(s)		This study is an intervention study designed to artificially create conditions in which the amount and timing of meals are restricted.
Health Condition(s) Keyword		ALS
Intervention(s) Keyword		food
Health Condition(s) Code		D000690
Intervention(s) Code		D005502
Primary Outcome(s)		acylated ghrelin concentrations 1 hour before and after meals the change in acylated ghrelin concentrations between pre- and post-meal levels

Primary Sponsor	None

Secondary Sponsor

Name of Certified Review Board	Kochi Medical School Hospital Certified Clinical Research Review Board
Address	185-1 Kohasu,Oko-cho,Nankoku-shi,Kochi, Kochi
Telephone	+81-88-880-2180
E-Mail	is21@kochi-u.ac.jp
Approval Status	Approval
Date of approval	May. 28, 2026

Plan to share IPD	Yes

Countries of Recruitment（Except Japan）	None