The purpose of this study is to determine the health benefits of cranberry extract in people who are at risk for diabetes and heart problems.
This study will be a double-blinded, randomized, placebo-controlled, pilot study in which subjects with pre-diabetes will be randomized to receive either placebo or Cranberry extract for a total of 8 weeks of treatment. Each subject will continue on the same dosage of cranberry extract or matching placebo for the entire duration of treatment. Comparisons for insulin sensitivity, endothelial function, and markers of inflmmation and oxidative stress will be made between the 2 groups pre and post intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
35
Participants will drink one 15.2 oz bottle of Cranberry Extract beverage daily for 8 weeks.
Participants will drink one 15.2oz bottle of placebo beverage daily for 8 weeks.
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Change from baseline Hyperinsulinemic-Euglycemic clamp at week 8
Insulin sensitivity is tested using a 120 mU/m2 hyperinsulinemic-euglycemic clamp at 100mg/dL glucose over 2 hours at weeks 0 and 8
Time frame: 8 weeks +/- 2 days
Change from baseline in endothelial function at week 7
Endothelial function by peripheral arterial tone (PAT) with an endo-PAT device prior to week 0 and week 7 as a surrogate measure of atherosclerosis.
Time frame: 8 weeks +/- 2 days
Change from baseline in Indirect Calorimetry at week 8
Resting metabolic rate via indirect calorimetry will be measured using a Deltatrac II Metabolic cart at week 0 and week 8 as part of the hyperinsulinemic euglycemic clamp.
Time frame: 8 weeks +/- 2 days
Change from screening to week 8 in lipid profile
A comprehensive metabolic profile (CHEM 15) will be obtained at screening and then at week 8.
Time frame: 10 weeks +/- 2 days
Change in body weight from baseline to week 8
Body weight will be assessed at baseline and week 8.
Time frame: 8 weeks +/- 2 days
Change from screening to week 7 in oral glucose tolerance test (OGTT)
A 2 hr OGTT will be performed prior to week 0 and at week 7
Time frame: 8 weeks +/- 2 days
Change in nitric oxide level at baseline and week 8
Levels of nitric oxide will be assessed at baseline and after 8 weeks of intervention
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Time frame: 8 weeks +/- 2 days
Change in endothelin 1 level at baseline and week 8
Levels of endothelin 1 will be assessed at baseline and after 8 weeks of intervention
Time frame: 8 weeks +/- 2 days
Change in oxidized LDL level at baseline and week 8
Levels of oxidized LDL will be assessed at baseline and after 8 weeks of intervention
Time frame: 8 weeks +/- 2 days
Change in LOX-1 (Lectin-like oxidized low density lipoprotein-1) at baseline and week 8
Levels of LOX-1 (Lectin-like oxidized low density lipoprotein-1) will be assessed at baseline and after 8 weeks of intervention
Time frame: 8 weeks +/- 2 days
Change in 8-isoprostanes at baseline and week 8
Levels of 8-isoprostanes will be assessed at baseline and after 8 weeks of intervention
Time frame: 8 weeks +/- 2 days
Change in malondialdehyde at baseline and week 8
Levels of malondialdehyde will be assessed at baseline and after 8 weeks of intervention
Time frame: 8 weeks +/- 2 days
Change in advanced glycation end products at baseline and week 8
Levels of advanced glycation end products will be assessed at baseline and after 8 weeks of intervention
Time frame: 8 weeks +/- 2 days
Change in Apo A1 at baseline and week 8
Levels of Apo A1 will be assessed at baseline and after 8 weeks of intervention
Time frame: 8 weeks +/- 2 days
Change in Paraoxonase at baseline and week 8
Levels of Paraoxonase will be assessed at baseline and after 8 weeks of intervention
Time frame: 8 weeks +/- 2 days
Change in Adiponectin at baseline and week 8
Levels of Adiponectin will be assessed at baseline and after 8 weeks of intervention
Time frame: 8 weeks +/- 2 days
Change in C-reactive protein (CRP) at baseline and week 8
Levels of C-reactive protein (CRP) will be assessed at baseline and after 8 weeks of intervention
Time frame: 8 weeks +/- 2 days
Change in TNFα at baseline and week 8
Levels of TNFα will be assessed at baseline and after 8 weeks of intervention
Time frame: 8 weeks +/- 2 days