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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210730007
Enrollment
30
Registered
2021-07-30
Start date
2021-11-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes prediabetes impaired fasting glucose obesity diabetes glycemic index postprandial glucose rice medical food

Interventions

Subjects are asked to drink rice-based diabetes-specific medical food (liquid) which contains 25g of carbohydrates within 12-15 minutes. Blood is drawn at baseline and 15,30,45,60,90,120 minutes to me
Experimental Dietary Supplement,Experimental Dietary Supplement,Active Comparator Dietary Supplement,Active Comparator Dietary Supplement
rice-based diabetes-specific medical food (liquid),rice-based diabetes-specific medical food (powder),commercially-available medical food (non-diabetes),commercially-available diabetes-specific medic

Sponsors

Agricultural Research Development Agency (ARDA)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
postprandial glucose area under the curve (AUC) 0-120min glucose AUC after each intervention

Secondary

MeasureTime frame
postprandial insulin area under the curve (AUC) 0-120min insulin AUC after each intervention

Countries

Thailand

Contacts

Public ContactPornpoj Pramyothin

Mahidol University

pornpoj.pra@mahidol.edu024199322

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026