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

JRCT ID: jRCTs061230021

Registered date:07/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 03/09/2023
• Target sample size: 24
• Study type: Interventional

Intervention(s)

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 piece of D-allulose-containing Jelly contains 5 g of D-allulose. Jelly containing sucralose contains 0.0064 g of sucralose per jelly.

B: Sucralose-containing Jell-O prior to ingestion
Diabetic patients hospitalized for 2 days on sucralose-containing jelly with 3 meals a day (diabetic diet), followed by a washout period of at least 1 day and 2 days on D-allulose-containing jelly with 3 meals a day (diabetic diet). Each piece of sucralose-containing jelly contains 0.0064 g of sucralose; 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 22 kg/m2) x 30 kcal (moderate activity as physical activity) kcal.

Outcome(s)

• Primary Outcome: Use a continuous glucose meter to compare peak postprandial blood glucose levels.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Fukunaga Kensaku