Evaluation of a Nutritional Product for People With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The objective of this trial is to evaluate a nutritional product for people with Diabetes.

Official Title
-----------------
Evaluation of a Nutritional Product for People With Type 2 Diabetes (T2DM)

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: Experimental Study Product
* Other: Control Study Product


Participation Criteria
=================
Eligibility Criteria
-----------------
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 is > 18.5 kg/m2 and < 40.0 kg/m2. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Study Product<br>1 serving of a nutritional product for people with diabetes. | Other: Experimental Study Product<br> <br> * Other names: Oral nutritional supplement for people with Diabetes.;|
| Placebo Comparator: Control Study Product<br>1 serving of control beverage. | Other: Control Study Product<br> <br> * Other names: Water beverage.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hunger | An appetite questionnaire administered 0 to 300 minutes during each study visit. | Treatment Visit Week 1 and Treatment Visit Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fullness | An appetite questionnaire administered 0 to 300 minutes during each study visit. | Treatment Visit Week 1 and Treatment Visit Week 2 | 
| Desire to Eat | An appetite questionnaire administered 0 to 300 minutes during each study visit. | Treatment Visit Week 1 and Treatment Visit Week 2 | 
| Prospective Consumption | An appetite questionnaire administered 0 to 300 minutes during each study visit. | Treatment Visit Week 1 and Treatment Visit Week 2 |