Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics

Study Overview
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Brief Summary
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To compare the postprandial glycemic and insulinemic response of subjects with type 2 diabetes consuming a typical breakfast meal or no breakfast to 10004RF via a meal tolerance test (MTT).

Official Title
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Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: No breakfast/beverage only
* Other: Breakfast
* Other: 10004RF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes between 21 and 75 years of age male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile BMI is > 18.5 kg/m2 and <35 kg/m2 If subject is on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, they have been on constant dosage for at least two months prior to screening visit. Exclusion Criteria: Hemoglobin A1c value at screening of greater than or equal to 9%. Uses exogenous insulin or exenatide for glucose control. type 1 diabetes. history of diabetic ketoacidosis. current infection; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit. active malignancy significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure. end-stage organ failure or is status post organ transplant. history of renal disease. current hepatic disease. history of severe gastroparesis. chronic, contagious, infectious disease taking any herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, that could profoundly affect blood glucose. clotting or bleeding disorders allergic or intolerant to any ingredient found in the study products. habitual user of tobacco products (

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No breakfast/beverage only<br>12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener | Other: No breakfast/beverage only<br>* 12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener<br>|
| Active Comparator: Breakfast<br>1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener | Other: Breakfast<br>* 1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener<br>|
| Experimental: 10004RF<br>1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener | Other: 10004RF<br>* 1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive AUC for plasma glucose concentration |  | 0 to 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose concentrations |  | 0 to 180 minutes | 
| Positive AUC for serum insulin concentration |  | 0-180 minutes |