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Intervention study on the consumption of donuts containing Lakanto D-allulose blend in patients with type 2 diabetes mellitus

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Type 2 diabetes
Date of first enrollment	26/09/2025
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	Group A: Lakanto D-allulose blend donut-first group Hospitalized patients with type 2 diabetes will consume donuts containing the Lakanto D-allulose blend once daily as breakfast. After a washout period of at least one day, they will consume donuts containing Lakanto S once daily as breakfast. The Lakanto D-allulose blend donuts contain 6 g of D-allulose per two donuts. The Lakanto S donuts contain 6 g of erythritol per two donuts. Group B: Lakanto S donut-first group Hospitalized patients with type 2 diabetes will consume donuts containing Lakanto S once daily as breakfast. After a washout period of at least one day, they will consume donuts containing the Lakanto D-allulose blend once daily as breakfast. The Lakanto D-allulose blend donuts contain 6 g of D-allulose per two donuts. The Lakanto S donuts contain 6 g of erythritol per two donuts.

Outcome(s)

Primary Outcome	Comparison of postprandial glucose peak levels using a continuous glucose monitoring (CGM) device.
Secondary Outcome	Area under the curve(AUC) for 2 hours postprandially as measured by CGM. Patient satisfaction questionnaire, including taste evaluation. Changes in glycemic control before and after each intervention phase. Variations in clinical laboratory test values. Changes in oral health status.

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	1.Patients aged 20 years or older at the time of obtaining informed consent. 2.Hospitalized patients with type 2 diabetes mellitus at our institution (excluding those with diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome). 3.Patients who are able to provide written informed consent for participation in this study.
Exclude criteria	1. Patients with a history of serious adverse reactions to D-allulose administration. 2. Pregnant women, postpartum women, lactating women, or women who may be pregnant. 3. Patients with severe renal impairment (serum eGFR < 15 mL/min/1.73 m^2). 4. Patients with other serious comorbidities. 5. Patients for whom the principal investigator or co-investigator determines that participation in the study is not in the best interest of the subject (e.g., may compromise the subject's welfare), or whose participation may interfere with, limit, or confound the specific evaluations required by this study protocol. 6. Employees of the principal investigator, co-investigators, or the study site who are directly involved in the conduct of this or other clinical studies, or their family members.