Diabetes
Conditions
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.
Interventions
OTHERBoost Glucose Control (A)
Oral nutrition supplement
OTHERBoost Glucose Control (B)
Oral nutrition supplement
OTHERBoost Original
Oral nutrition supplement
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the blood glucose curve (AUC 0-240) | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Area under the insulin curves (AUC 0-240) | 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 |
| AUC (0-30min) for insulin | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes |
Countries
United States
Outcome results
None listed