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

A single-blind, crossover comparative study on the efficacy of donuts containing Lakanto D-allulose blend in patients with type 2 diabetes mellitus

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061250039

Enrollment

Registered

2025-07-18

Start date

2025-09-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes Type 2 diabetes

Interventions

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 peri

D-Allulose, The Lakanto D-allulose blend

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Comparison of postprandial glucose peak levels using a continuous glucose monitoring (CGM) device.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactKensaku Fukunaga

Kagawa University Hospital

fukunaga.kensaku@kagawa-u.ac.jp+81-878912230

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026