Glycemic Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: Boost Glucose Control (B); Other: Boost Original; Other: Boost Glucose Control (A)

• Registration Number: NCT02856516
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

This will be a randomized, cross-over design. Subjects will be randomized to one of three interventions on three separate study days, 1 week apart.

Detailed Description

Following consent, subjects will be randomized to one of three arms. After an overnight fast an intravenous line will be placed for blood withdrawal. The subject will then consume the randomly assigned intervention. Blood samples for glucose and insulin levels will be drawn at specified intervals after the product has been consumed.

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Primary Completion: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Study Completion: 2016-09
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
• Hemoglobin A1C less than 9.0%
• Fasting blood glucose less than 180 mg

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
• Unable to give informed consent or follow instructions
• Current insulin therapy or insulin therapy within the past month
• Patients 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
• Currently participating or having participated in another clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Boost Glucose Control (B)	Boost Glucose Control (B)	Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.
Boost Original	Boost Original	Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption.
Boost Glucose Control (A)	Boost Glucose Control (A)	Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.

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

Secondary Outcome Measures

Name	Time	Method
Area under the insulin curves (AUC 0-240)	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
AUC (0-30min) for insulin	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Insulinogenic index (Ins30/(Glu30)	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Trial Locations

Locations (1)

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