Diabetes
Conditions
Brief summary
The objective of this trial is to evaluate a nutritional product for people with Diabetes.
Interventions
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects will be eligible for the study if they meet all of the following inclusion criteria: 1. Diagnosis of Type 2 Diabetes. 2. Age between 18 and 75 years. 3. HbA1c \> 6.0 but ≤ 8.5 4. If female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration. 5. BMI is \> 18.5 kg/m2 and \< 40.0 kg/m2. 6. Chronic medication dosage must be stable for at least two months prior to Screening Visit. 7. Subject states that they are a habitual consumer of a morning meal.
Exclusion criteria
* Subjects will be excluded from the study if they meet any of the following criteria: 1. Use of exogenous insulin or GLP-1 agonists for glucose control. 2. Diagnosis of Type 1 diabetes. 3. History of diabetic ketoacidosis. 4. Current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks. 5. Active malignancy. 6. Significant cardiovascular event \< 12 weeks prior to study entry. 7. End stage organ failure or status post organ transplant. 8. Active metabolic, hepatic, or gastrointestinal disease. 9. Chronic, contagious, infectious disease. 10. Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose. 11. History of fainting or other adverse reactions in response to blood collection. 12. Clotting or bleeding disorders. 13. Allergy or intolerance to study product ingredient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hunger | Treatment Visit Week 1 and Treatment Visit Week 2 | An appetite questionnaire administered 0 to 300 minutes during each study visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fullness | Treatment Visit Week 1 and Treatment Visit Week 2 | An appetite questionnaire administered 0 to 300 minutes during each study visit. |
| Desire to Eat | Treatment Visit Week 1 and Treatment Visit Week 2 | An appetite questionnaire administered 0 to 300 minutes during each study visit. |
| Prospective Consumption | Treatment Visit Week 1 and Treatment Visit Week 2 | An appetite questionnaire administered 0 to 300 minutes during each study visit. |
Countries
United States
Outcome results
None listed