The Influence Of Cranberry Juice On Risk Factors For Cardiovascular Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Disease
- Sponsor
- United States Department of Agriculture (USDA)
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in biomarkers of cardiovascular disease and polyphenol absorption
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
Previous studies have shown that consumption of a low calorie cranberry beverage imparts a favorable impact on HDL cholesterol, LDL oxidation, and cell adhesion molecules in men. However, these studies were not well controlled. Thus, it is important to confirm these effects in a blinded, placebo-controlled feeding study. The investigators goal is to verify the cardioprotective effects of cranberries by conducting a dietary intervention trial with healthy subjects in a controlled environment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •25 to 65 years of age
- •BMI 20 to 38 kg/m2
Exclusion Criteria
- •history of bariatric or certain other surgeries related to weight control
- •kidney disease, liver disease, certain cancers, gout, hyperthyroidism, untreated or unstable hypothyroidism, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- •Type 2 diabetes or use of glucose-lowering medication
- •Have a fasting blood sugar greater than 126 mg/dL
- •LDL-cholesterol less than 130 mg/dL
- •fasting triglycerides greater than 300 mg/dL
- •use of cholesterol-lowering medication or supplements
- •use of blood pressure-lowering medication
- •smoking or use of other tobacco products (within 6 months prior to the start of the study)
- •unwillingness to abstain from vitamin, mineral, and herbal supplements for 2 weeks prior to the study and during the study
Outcomes
Primary Outcomes
Change in biomarkers of cardiovascular disease and polyphenol absorption
Time Frame: Days 1&2; Days 27&28; Days 55&56
A blood lipid panel will include plasma total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Apo A-1, Apo A-II, Apo B, Lpa. Inflammatory markers (IL-6, IL-10, IL-1-alpha, CRP, TNF-alpha, fibrinogen, iCAM) will be determined by ELISA. Serum will be analyzed for polyphenol concentration.
Secondary Outcomes
- Change from baseline in systolic and diastolic blood pressure(Days 1, 28, and 56)
- Change in urine metabolomics and adhesion analysis(Days 1 & 56)
- Change in fecal microbiota(Days 1 & 56)