Clinical study on effectiveness of diabetic diet containing rare sugar D-allulose in patients with type 2 diabetes

JRCT ID: jRCTs061200022

Registered date:14/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 03/12/2020
• Target sample size: 24
• Study type: Interventional

Intervention(s)

A: Diabetes diet precedent group
After being hospitalized, eat a diabetic diet three times a day for two days. After a washout period of 1 day, a rare sugar-containing diabetic diet is taken 3 times a day for 2 days. The rare sugar-containing diabetic diet contains 8.5 g of D-allulose per serving.

B: Rare sugar-containing diabetic diet precedent group
After being hospitalized, take a diabetic diet containing rare sugars 3 times a day for 2 days. After a washout period of 1 day, eat a diabetic diet 3 times a day for 2 days. The rare sugar-containing diabetic diet contains 8.5 g of D-allulose per serving.

Outcome(s)

• Primary Outcome: The postprandial blood glucose peak value is comparatively examined using a Flash Glucose Monitoring.

Secondary Outcome

AUC 2 hours after meal when using continuous blood glucose meter
Blood/urine D allulose concentration
Questionnaire of patient satisfaction including seasoning
Change in weight change
Control status of diabetes before and after ingestion of each diet group
Changes in various laboratory test values

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Patients with type 2 diabetes whose age at the time of obtaining consent is 20 to 80 years old.
2. Hospitalized type 2 diabetic patients. (HbA1c 6.5% or more)
3. Patients with written informed consent to participate in this study.

Exclude criteria

1. Patients taking an a-glucosidase inhibitor
2. Patients with a history of serious side effects after taking D-allulose in the past
3. Pregnant, maternity, lactating or potentially pregnant women
4. Patients with severe renal impairment (serum creatinine level of 1.5 mg/dl or higher)
5. Patients with other serious complications
6. Patients participating in other trials
7. According to the opinion of the investigator, etc., if participation in the research does not maximize the benefit of the research target (such as impairing the welfare of the research target), or obstructing, limiting, or confusing the evaluation specific to the clinical research implementation plan. If it is determined to do.
8. Under the direction of the investigator, etc. or the conducting medical institution, the investigator of the investigator or the conducting medical institution directly involved in this research or other clinical research, or such employee or the investigator Family

Related Information

• Primary Sponsor: Imachi Hitomi
• Source(s) of Monetary Support: "Kagawa Rare Sugar White Valley Project"