臨床研究等提出・公開システム

Japanese

Date of registration	April. 08, 2026
Last modified on	April. 08, 2026
Trial ID	jRCT1050260015

Scientific Title	Effects of cereal consumption on postprandial glucose variability: The second-meal effect
Public Title	Second-meal effect of cereal on blood glucose

Contact for Scientific Queries	Name	Suzuki A Yasushi
	Affiliation	Mukogawa Women's University
	Address	6-46, Ikebiraki-cho, Nishinomiya, Hyogo
	Telephone	+81-798-45-9927
	E-mail	yasuzuki@mukogawa-u.ac.jp
Contact for Public Queries	Name	Suzuki A Yasushi
	Affiliation	Mukogawa Women's University
	Address	6-46, Ikebirakicho, Nishinomiya, Hyogo
	Telephone	+81-798-45-9927
	E-mail	yasuzuki@mukogawa-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 08, 2026
Target sample size		15
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	crossover assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	The study subjects consist of a total of 15 healthy female volunteers, aged 20 to 30 years. All participants are either undergraduate students from the School of Food Science and Nutrition, or graduate students majoring in Food Science and Nutrition or Innovative Food Sciences at Mukogawa Women's University.
	Exclusion Criteria	Diagnosed with diabetes mellitus in the most recent periodic health examination. Currently taking medications, such as antihypertensive drugs. Habitual smokers. Body Mass Index (BMI) of 30 kg/m2 or higher.
	Age Minimum	20age 0month 0week old over
	Age Maximum	30age 0month 0week old under
	Gender	Female
Health Condition(s) or Problem(s) Studied		Healthy volunteers
Intervention(s)		Single intake cereal containing indigestible carbohydrates with milk for breakfast. Four hours after intake, a standard meal (white rice) is consumed, followed by blood glucose measurement for 180 minutes.
Health Condition(s) Keyword		Healthy volunteers, Postprandial Period
Intervention(s) Keyword		Blood glucose, Dietary Fiber, Edible grain
Health Condition(s) Code		D064368, D019518
Intervention(s) Code		D001786, D004043, D002523
Primary Outcome(s)		Incremental Area Under the Curve (iAUC) for blood glucose from 0 to 180 minutes after lunch [Unit: mg min/dL] Maximum change in blood glucose concentration (delta Cmax) after lunch [Unit: mg/dL] Blood glucose levels at each time point (0, 30, 60, 90, 120, and 180 min) after lunch [Unit: mg/dL]
Secondary Outcome(s)		Incremental Area Under the Curve (iAUC) for blood glucose and blood glucose levels at each time point from breakfast to before lunch. Satiety and hunger scores measured by Visual Analogue Scale (VAS) Assessment of adverse events and gastrointestinal symptoms (e.g., abdominal bloating, diarrhea) via interviews

Source of Monetary Support	Domestic Food Company

Name of Certified Review Board	Research Ethics Committee, Research Promotion Center, Mukogawa Women's University
Address	6-46, Ikebiraki-cho, Nishinomiya, Hyogo
Telephone	+81-798-45-3575
E-Mail	sienka@mukogawa-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 21, 2026

Plan to share IPD	No
Plan description	There are no plans to share individual participant data.

Secondary ID(s)	なし

Countries of Recruitment（Except Japan）	none