A Single Research Site, Comparator Study of Raisins Versus Alternative Snacks on Glycemic Control and Other Cardiovascular Risk Factors in Patients With Type 2 Diabetes Mellitus
The objective of this study is to compare the effects of Raisins three times per day versus alternative snacks three times per day on blood sugar control and cardiovascular risk factors (weight, waist circumference, blood pressure, cholesterol levels) in patients with Type 2 Diabetes Mellitus. These effects will be studied over a 12 week period.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Unblinded, Single Research Site, Comparator Study of Raisins Versus Alternative Snacks on Glycemic Control and Other Cardiovascular Risk Factors in Patients With Type 2 Diabetes Mellitus|
- Blood Glucose Control [ Time Frame: 12-14 weeks ] [ Designated as safety issue: No ]
- Postprandial glucose levels
- Hemoglobin A1c
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.
1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm
Active Comparator: Snack Group
Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.
100 calorie snack packs will be administered to the subjects in the snack group
Other Name: 100 calorie snack packs
Raisins are often considered a good food choice because they provide dietary fiber and many health-promoting nutrients, antioxidants and phytochemicals. Like most other fruits, raisins are devoid of fat, saturated fat and cholesterol, and low in sodium; these features, combined with their high potassium content, high fiber, and low glycemic index make them potentially preferable to other foods in their effects upon glycemic control and cardiovascular risk factors.
|Contact: Kathy Schmitz, BSNfirstname.lastname@example.org|
|Contact: Melanie Moore, MSNemail@example.com|
|United States, Kentucky|
|L-MARC Research Center||Recruiting|
|Louisville, Kentucky, United States, 40213|
|Contact: Kathy M Schmitz, BSN 502-214-3990 firstname.lastname@example.org|
|Principal Investigator: Harold E Bays, MD|
|Principal Investigator:||Harold E Bays, MD||L-MARC Research Center|