臨床研究等提出・公開システム

Japanese

Date of registration	April. 03, 2024
Last modified on	Feb. 17, 2026
Trial ID	jRCT1041240002

Scientific Title	An intervention study on effects of matcha green tea consumption on cognitive function in older adults
Public Title	Study for effects of Matcha on cognition

Contact for Scientific Queries	Name	Ono Kenjiro
	Affiliation	Kanazawa University Hospital
	Address	13-1, Takara-machi, Kanazawa, Ishikawa
	Telephone	+81-76-265-2000
	E-mail	onoken@med.kanazawa-u.ac.jp
Contact for Public Queries	Name	Shinohara Moeko
	Affiliation	Kanazawa University Hospital
	Address	13-1, Takara-machi, Kanazawa, Ishikawa
	Telephone	+81-76-265-2000
	E-mail	m-nohara@med.kanazawa-u.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		April. 03, 2024
Target sample size		40
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Individuals who visit Kanazawa University Hospital Neurology Outpatient Department 2) Men and women aged 50 to under 90 on the date of consent 3) Score of Montreal cognitive assessment Japanese version (MoCAJ) is 25 points or less 4) Individuals who can consume matcha or barley tea and be able to record the consumption. 5) Individuals who agree not to make extreme lifestyle changes such as exercise habits or eating habits while participating in the study. 6) Individuals who have obtained sufficient informed consent and written consent of the subject's own free will to participate in the research.
	Exclusion Criteria	1) Individuals who have a history of allergies to matcha or barley tea 2) People who have a habit of drinking matcha or barley tea every day 3) Individuals who have the habit of consuming large amounts of tea (any type) every day (approximately 10 cups, 2000ml or more) 4) Individuals who are taking warfarin 5) People with dementia
	Age Minimum	50age old over
	Age Maximum	90age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Mild cognitive impairment
Intervention(s)		Matcha 1.5g stick: Drink 1 cup per day, dissolved in water or hot water, before or between meals. Barley tea 0.8g stick: Dissolve in water or hot water and drink 1 cup per day, before or between meals.
Health Condition(s) Keyword		Cognitive decline, Alzheimer's disease
Intervention(s) Keyword		Matcha, Barley tea, tea
Health Condition(s) Code		D060825
Intervention(s) Code		D013662
Primary Outcome(s)		Montreal cognitive assessment Japanese version (MoCA-J) score change: MoCA-J score change from screening 24 weeks after intake
Secondary Outcome(s)		Changes in NouKNOW, Minimental state examination Japanese version (MMSE-J), DASC-21 score, cerebral white matter lesions and brain volume (global, regional) on head MRI 24 weeks after intake Amount of change, relationship between changes in intestinal flora from baseline after 24 weeks of intake and cognitive function

Primary Sponsor	Department of Neurology, Kanazawa University Hospital

Source of Monetary Support / Secondary Sponsor	Itoen Co., Ltd. Aiya Co., Ltd.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Clinical Trial Review Board of Kanazawa University Hospital
Address	13-1, Takara-machi, Kanazawa, Ishikawa
Telephone	+81-76-265-2048
E-Mail	hpsangak@adm.kanazawa-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 21, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
3	Feb. 17, 2026	(this page)	Changes
2	Feb. 05, 2026	Detail	Changes
1	April. 03, 2024	Detail

List of change history