Glycemic Response in Adults with Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Balance oral nutritional drink - control; Other: Balance oral nutritional drink - test

• Registration Number: NCT05026424
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

This will be a randomized crossover design with oral nutrition supplement interventions.

Detailed Description

This will be a randomized crossover design with two oral nutrition supplement interventions. The subjects will be randomized to one of two interventions on two separate study days, one week apart.

Study Timeline

• Study Start: 2021-08-02
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-30
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Age 20-75 years
• Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
• Hemoglobin A1C less than 9.0%
• Fasting blood glucose less than 180 mg/dl
• Hematocrit levels within normal limits
• Having obtained his/her informed consent

Exclusion Criteria

• Abnormal thyroid function
• Creatinine >2.0 mg/dl
• Potassium <3.5 mEq/l
• Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
• Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
• Patients with anemia
• Current insulin therapy or insulin therapy within the past month
• Patient who are pregnant
• Allergies to milk, soy or any component of the test product
• Patient who in the investigators assessment cannot be expected to comply with treatment
• Patients with anemia
• Currently participating in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Comparator: Oral Nutrition Supplement Control	Balance oral nutritional drink - control	The control study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition.
Active Comparator: Oral Nutrition Supplement Test	Balance oral nutritional drink - test	The test study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition for people living with diabetes.

Primary Outcome Measures

Name	Time	Method
Post-prandial glycemic markers	[Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]	Area under the blood glucose curve (AUC 0-240 minutes)

Secondary Outcome Measures

Name	Time	Method
Post-prandial insulin markers	[Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]	Area under the insulin curve (AUC 0-240 minutes)
Insulinogenic index	[Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]	Insulinogenic index (change in Ins30/change in Glu30)

Trial Locations

Locations (1)

Orange County Research Center; 🇺🇸 Tustin, California, United States