Diabetes Mellitus, Type 2
Conditions
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.
Interventions
OTHERBalance oral nutritional drink - control
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition.
OTHERBalance oral nutritional drink - test
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat designed for people living with diabetes and intended for use as supplemental nutrition.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Site pharmacy will not be blinded to product assignment, study staff and participants will be blinded to product assignment. Product will be provided in unlabeled cups.
Intervention model description
This will be a randomized crossover design. The subjects will be randomized to one of two interventions on two separate study days, one week apart.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed