NCT01850134WithdrawnNot Applicable
Evaluation of a Nutritional Supplement for People With Type 2 Diabetes (T2DM).
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Abbott Nutrition
- Locations
- 2
- Primary Endpoint
- Hunger
Study Overview
Brief Summary
The objective of this trial is to evaluate a nutritional supplement for people with Diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects will be eligible for the study if they meet all of the following inclusion criteria:
- •Diagnosis of Type 2 Diabetes.
- •Age between 18 and 75 years.
- •HbA1c > 6.0 but ≤ 8.5
- •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.
- •BMI > 18.5 kg/m2 and < 40.0 kg/m
- •Chronic medication dosage must be stable for at least two months prior to Screening Visit.
- •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:
- •Use of exogenous insulin or GLP-1 agonists for glucose control.
- •Diagnosis of Type 1 diabetes.
- •History of diabetic ketoacidosis.
- •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.
- •Active malignancy.
- •Significant cardiovascular event < 12 weeks prior to study entry.
- •End stage organ failure or status post organ transplant.
- •Active metabolic, hepatic, or gastrointestinal disease.
- •Chronic, contagious, infectious disease.
- •Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
- •History of fainting or other adverse reactions in response to blood collection.
- •Clotting or bleeding disorders.
- •Allergy or intolerance to study product ingredient.
Arms & Interventions
Control Study Product
Placebo Comparator
1 serving of control beverage.
Intervention: Control Study Product (Other)
Experimental Study Product
Experimental
1 serving of a nutritional supplement for people with diabetes.
Intervention: Experimental Study Product (Other)
Outcomes
Primary Outcomes
Hunger
Time Frame: Treatment Visit 1 and Treatment Visit 2
An appetite questionnaire evaluating change from baseline during each study visit.
Secondary Outcomes
- Prospective Consumption(Treatment Visit 1 and Treatment Visit 2)
- Fullness(Treatment Visit 1 and Treatment Visit 2)
- Desire to Eat(Treatment Visit 1 and Treatment Visit 2)
Investigators
Study Sites (2)
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