Verification study of blood glucose level fluctuation by consumption of rice cooked in a carbohydrate-cut rice cooker -A randomized, double-blind, crossover study-

UMIN ID: UMIN000050004

Registered date:10/01/2023

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 2023/01/11
• Target sample size: 24
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Single intake of white rice with 50% less sugar
Single intake of regular white rice

Outcome(s)

• Primary Outcome: The incremental area under the curve of the postprandial blood glucose
• Secondary Outcome: "The incremental area under the curve of postprandial blood insulin and triglyceride levels Cmax,delta Cmax, and Tmax of blood glucose, insulin, and triglyceride levels Postprandial questionnaire&quot

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. Subjects who have been diagnosed with diabetes by a physician. 2. Subjects who are currently receiving medication or outpatient treatment for some serious disease. 3. Subjects who are currently undergoing exercise or diet therapy under the supervision of a physician. 4. Subjects who may develop allergies to the test food. 5. Subjects who have a current or a history of drug dependence or alcohol dependence. 6. Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past. 7. Subjects who are with extremely irregular eating, sleeping, or other habits. 8. Subjects who have an extremely unbalanced diet. 9. Subjects who have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, liver diseases (hepatitis), kidney diseases, heart diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases. 10. Subject who use health foods and medicines that contain ingredients that affect blood glucose levels. 11. Subjects who have participated in other clinical trials (research) within 3 months retrospectively from the date of obtaining consent, or those who have plans to participate in other clinical trials (research) during the study period 12. Subjects who have collected more than 200 mL of blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent. 13. Subjects who are currently pregnant or breastfeeding. or who are likely to become so during the study period. 14. Subjects who have difficulty in complying with the recording of various questionnaires. 15. Subjects who are judged to be inappropriate as subjects based on clinical laboratory test values and measured values at the time of SCR. 16. Other subjects who are judged unsuitable as subjects by the principal investigator.

Related Information

• Primary Sponsor: Others
• Source(s) of Monetary Support: Others