Cardiovascular Disease Risk Factors
Conditions
Keywords
Cranberries, blood pressure, cholesterol, SphygmoCor
Brief summary
The purpose of this study is to evaluate the effects of cranberry juice on central and peripheral blood pressure, indices of arterial stiffness, lipid and lipoprotein concentrations and size characteristics, and HDL function. The investigators hypothesize that the bioactive compounds in cranberry juice may elicit beneficial effects on blood pressure and arterial health, as well as LDL-C and HDL function.
Detailed description
The investigators propose to conduct a 2-period randomized, crossover, placebo-controlled study to evaluate the effect of cranberry juice on central and peripheral blood pressure, indices of arterial stiffness, lipid and lipoprotein concentrations and size characteristics, and HDL function. Eligibility requires non-smoking men and women to be 30 to 65 years of age with BMI greater than or equal to 18 and less than or equal to 39, total cholesterol below 273 mg/dL for men and below 284 mg/dL for women, triglycerides below 350 mg/dL, and have systolic blood pressure of 120 to 159 mmHg and/or diastolic blood pressure of 80 to 99 mmHg. Subjects will undergo randomized treatments including 500 mL/d cranberry juice beverage and 500 mL/d of a color and taste matched placebo beverage. The two 8 to 12 week treatment periods will be separated by an 8 week washout.
Interventions
DIETARY_SUPPLEMENTCranberry Juice Beverage
16 ounces of 54% cranberry juice cocktail
DIETARY_SUPPLEMENTPlacebo Beverage
Color, calorie, and taste matched beverage without cranberry bioactives
Sponsors
Ocean Spray Cranberries, Inc.
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women 30-65 years of age 2. BMI ≥ 18 and ≤ 39 kg/m\^2 3. Total cholesterol below 273 mg/dL for men and below 284 mg/dL for women 4. Triglycerides below 350 mg/dL 5. Non-smokers 6. At least one of the following: 1. Systolic blood pressure 120-159 mmHg 2. Diastolic blood pressure 80-99 mmHg
Exclusion criteria
1. History of acute or chronic inflammatory conditions or heart disease, kidney disease, liver disease, autoimmune disorders, or thyroid disease (unless controlled by medication and blood results within previous 6 months are provided) 2. History of diabetes mellitus (and/or a fasting glucose \>126 mg/dL at screening) 3. Stage II hypertension (blood pressure ≥ 160/100 mmHg) 4. Lactation, pregnancy, or desire to become pregnant during the study 5. Unwillingness to discontinue nutritional supplements, herbs, or vitamins unless approved by investigator 6. Use of medications/supplements for elevated lipids, blood pressure, or glucose 7. Chronic use of non-steroidal anti-inflammatory or immunosuppressant medication 8. Conditions requiring the use of steroids 9. Unwillingness to refrain from blood donation prior to and during the study 10. Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator 11. Allergy or sensitivity to cranberry juice or any ingredient in the study beverages
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Blood Pressure | Change from baseline after 8 week treatments with cranberry and placebo | Aortic (central) blood pressure measured using the SphygmoCor system |
| Peripheral Blood Pressure | Change from baseline after 8 week treatments with cranberry and placebo | Peripheral blood pressure measured using the SphygmoCor system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulse Wave Velocity | Change from baseline after 8 week treatments with cranberry and placebo | Pulse wave velocity measured using the SphygmoCor system |
| LDL-C | Change from baseline after 8 week treatments with cranberry and placebo | LDL-C values calculated using the Friedewald equation |
| LDL Particle Size | Change from baseline after 8 week treatments with cranberry and placebo | LDL particle size measured using a Vertical Auto Profile (VAP) Test |
| Total Cholesterol | Change from baseline after 8 week treatments with cranberry and placebo | Total cholesterol values determined by enzymatic procedures |
| Triglycerides | Change from baseline after 8 week treatments with cranberry and placebo | Triglyceride values determined using enzymatic procedures |
| Efflux capacity of HDL | Change from baseline after 8 week treatments with cranberry and placebo | Ability to carry out reverse cholesterol transport measured using in vitro assay |
| Oxidized LDL (oxLDL) | Change from baseline after 8 week treatments with cranberry and placebo | Plasma concentrations of oxLDL will be measured using ELISA kits |
| Malondialdehyde (MDA) | Change from baseline after 8 week treatments with cranberry and placebo | MDA will be measured using the thiobarbituric acid reactive substances (TBARS) assay |
| High Sensitivity C Reactive Protein (hs-CRP) | Change from baseline after 8 week treatments with cranberry and placebo | hs-CRP will be measured by latex-enhanced immunonephelometry |
| 24-hr Ambulatory Blood Pressure | Change from baseline after 8 week treatments with cranberry and placebo | — |
| HDL-C | Change from baseline after 8 week treatments with cranberry and placebo | HDL-C will be estimated according to the modified heparin-manganese procedure |
| Augmentation Index | Change from baseline after 8 week treatments with cranberry and placebo | Augmentation index measured using the SphygmoCor system |
Countries
United States
Outcome results
None listed