Development of medical food products for patients with and without diabetes mellitus using whole milk or lactose-free milk plus rice as the main ingredients to replace imported products

Phase 3

• Conditions: healthy volunteers; glycemic index, postprandial glucose, medical food

• Registration Number: TCTR20221221002
• Lead Sponsor: Agricultural Research Development Agency (ARDA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-21
• Study Completion: 2023-04-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Unknown
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. age 18 years and older
2. fasting plasma glucose < 100mg/dL
3. no prior history of diabetes and no prior treatment with glucose-lowering drugs
4. no history of food allergy
5. participants taking aspirin, birth control pills, vitamins and supplements, anti-hypertensive drugs, osteoporosis drugs at stable doses for 1 month or more are eligible for study inclusion

Exclusion Criteria

1. significant medical problems requiring ongoing treatment, including but not limited to cancer, cardiac,
pulmonary, hepatic, brain diseases or severe infection within 1 year before study inclusion
2. surgery or hospital admission within 3 months before study inclusion
3. history of allergy to medical food and lactose (or one or more of its components) used in the current study
4. pregnancy and lactation
5. use of thyroid hormones
6. history of diabetes or previous use of glucose-lowering drugs or insulin
7. diagnosis of diseases which significantly affect food digestion and absorption such as inflammatory bowel
disease, Crohn's disease, ulcerative colitis
8. treatment with medications which can affect blood glucose levels, such as steroids, protease inhibitors,
and antipsychotic drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic index, postprandial glucose area under the curve (AUC) 0-120min glycemic index equals (glucose AUC from medical food) / (glucose AUC from 50g glucose )

Secondary Outcome Measures

Name	Time	Method
Insulin response, insulin AUC 0-120 min Insulin response, insulin AUC