Development of rice-based medical food for patients with diabetes mellitus: Clinical study of medical food efficacy in diabetes mellitus or prediabetes patients

Phase 3

Completed

• Conditions: diabetesprediabetesimpaired fasting glucoseobesity; diabetes; glycemic index; postprandial glucose; rice; medical food

• Registration Number: TCTR20210730007
• Lead Sponsor: Agricultural Research Development Agency (ARDA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-30
• Study Completion: 2022-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. aged 18-60 years old
2. body mass index between 25-35 kg/m2
3. diagnosed with diabetes within 6 years of enrollment OR diagnosed with prediabetes either by fasting plasma glucose >=126 mg/dL or HbA1c >=5.7%
3. diabetes is being treated by lifestyle therapy alone or in conjunction with oral glucose-lowering drugs

Exclusion Criteria

1. receives insulin
2. prior history of gastroparesis
3. HbA1c >9% or diagnosed with diabetes >6 years prior to enrollment
4. blood pressure >= 180/110 mmHg or triglyceride levels >500 mg/dL
5. prior history of severe hyperglycemic or severe hypoglycemic episodes requiring hospitalization within 1 year of enrollment
6. severe medical problems requiring ongoing treatment, including but not limited to cancer, cardiac, pulmonary, hepatic, brain diseases or severe infections within 1 year of enrollment
7. history of surgery or hospitalization within 2 weeks of enrollment
8. history of allergy to medical foods (or its components) used in this study
9. body weight change of 5kg or more within 6 weeks of enrollment
10. pregnancy and lactation
11. prior history of bariatric surgery
12. diagnosis of diseases which significantly affect food digestion and absorption such as inflammatory bowel disease, Crohn's disease, ulcerative colitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postprandial glucose area under the curve (AUC) 0-120min glucose AUC after each intervention

Secondary Outcome Measures

Name	Time	Method
postprandial insulin area under the curve (AUC) 0-120min insulin AUC after each intervention