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

Nestlé

Status: Completed

Conditions: Diabetes

Treatments: Other: Boost Glucose Control (B); Other: Boost Glucose Control (A); Other: Boost Original

Study type: Interventional

Funder types: Industry

Identifiers

NCT02856516

15.11.US.HCN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 3 patient groups

Boost Glucose Control (A)

Experimental group

Description:

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.

Treatment:

Other: Boost Glucose Control (A)

Boost Glucose Control (B)

Experimental group

Description:

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.

Treatment:

Other: Boost Glucose Control (B)

Boost Original

Active Comparator group

Description:

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption.

Treatment:

Other: Boost Original