Glycemic Response to Oral Nutrition Supplements

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: ONS

• Registration Number: NCT02612675
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

This will be a randomized, cross-over study of two oral nutrition supplements in individuals with Type 2 Diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2015-11
• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-11-20
• Last Update Submitted: 2015-11-20
• Study First Posted: 2015-11-24
• Last Update Posted: 2015-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Age 20-75 yrs
• Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
• Hemoglobin A1C less than 9.0%
• Fasting blood glucose less than 180 mg

Exclusion Criteria

• Allergy to milk protein or any other component of the formula

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low Carbohydrate ONS	ONS	Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption
Standard ONS	ONS	Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption

Primary Outcome Measures

Name	Time	Method
Area under the blood glucose curve (AUC 0-240)	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Trial Locations

Locations (1)

Diabetes & Glandular Disease Clinic, PA; 🇺🇸 San Antonio, Texas, United States