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Clinical Trial of Jelly Containing the Rare Sugar D-Alulose in Patients with Type 2 Diabetes Mellitus

A Single-Blind, Crossover Comparative Study of the Efficacy of Jelly Containing the Rare Sugar D-Alulose in Patients with Type 2 Diabetes Mellitus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061230021
Enrollment
24
Registered
2023-06-07
Start date
2023-09-03
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 D-allulose

Interventions

A: D-allulose-containing jelly feeding pre-treatment group Patients with diabetes mellitus were hospitalized and fed D-allulose-containing jelly three times a day (diabetic diet) for 2 days. Each piec
each piece of D-allulose-containing jelly contains 5 g of D-allulose. *The energy content of the diabetic diet is set to the usual diet calculated as: standard body weight (height (m) x height (m) x

Sponsors

Fukunaga Kensaku
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. patients with type 2 diabetes who are 20 years of age or older at the time of obtaining consent 2. patients with type 2 diabetes who are hospitalized in our hospital. 3. patients who can give written consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1. patients taking alpha-glucosidase inhibitors 2. patients who have experienced serious adverse reactions to D-alulose in the past 3. pregnant, lactating, or nursing women, or women of childbearing potential 4. patients with severe renal dysfunction (serum eGFR < 15 ml/min/1.73m2) 5. patients with other serious complications 6. patients who are participating in other studies 7. if, in the opinion of the Principal Investigator, participation in the research would not be in the best interest of the research subjects (e.g., would be detrimental to the welfare of the research subjects) or would interfere with, limit, or confound the evaluation specific to the clinical research protocol 8. an employee of the Principal Investigator or the institution, or a family member of such an employee or Principal Investigator, who is directly involved in this or other clinical research at the direction of the Principal Investigator or the institution.

Design outcomes

Primary

MeasureTime frame
Use a continuous glucose meter to compare peak postprandial blood glucose levels.

Secondary

MeasureTime frame
Percentage of AUC, TIR, TAR, and TBR for 2 hours of postprandial blood glucose when using a continuous glucose meter Comparison of average blood glucose levels every 15 minutes up to 180 minutes after ingestion of each jelly group Comparison of average IRI, CPR, and TG values before and 120 minutes after consumption of each jelly group Patient satisfaction questionnaire including taste, etc. Changes in body weight Change in oral conditions

Contacts

Public ContactKensaku Fukunaga

Kagawa university

fukunaga.kensaku@kagawa-u.ac.jp+81-87-891-2230

Outcome results

None listed

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