Effects of Cranberry Juice on Cardiovascular Risk Factors in a Placebo-controlled Crossover Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Penn State University
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Central Blood Pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women 30-65 years of age
- •BMI ≥ 18 and ≤ 39 kg/m^2
- •Total cholesterol below 273 mg/dL for men and below 284 mg/dL for women
- •Triglycerides below 350 mg/dL
- •Non-smokers
- •At least one of the following:
- •Systolic blood pressure 120-159 mmHg
- •Diastolic blood pressure 80-99 mmHg
Exclusion Criteria
- •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)
- •History of diabetes mellitus (and/or a fasting glucose >126 mg/dL at screening)
- •Stage II hypertension (blood pressure ≥ 160/100 mmHg)
- •Lactation, pregnancy, or desire to become pregnant during the study
- •Unwillingness to discontinue nutritional supplements, herbs, or vitamins unless approved by investigator
- •Use of medications/supplements for elevated lipids, blood pressure, or glucose
- •Chronic use of non-steroidal anti-inflammatory or immunosuppressant medication
- •Conditions requiring the use of steroids
- •Unwillingness to refrain from blood donation prior to and during the study
- •Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator
- •Allergy or sensitivity to cranberry juice or any ingredient in the study beverages
Arms & Interventions
Cranberry Juice Beverage
16 ounces of 54% cranberry juice cocktail
Intervention: Cranberry Juice Beverage (Dietary Supplement)
Placebo Beverage
Color, calorie, and taste matched beverage without cranberry bioactives
Intervention: Placebo Beverage (Dietary Supplement)
Outcomes
Primary Outcomes
Central Blood Pressure
Time Frame: Change from baseline after 8 week treatments with cranberry and placebo
Aortic (central) blood pressure measured using the SphygmoCor system
Peripheral Blood Pressure
Time Frame: Change from baseline after 8 week treatments with cranberry and placebo
Peripheral blood pressure measured using the SphygmoCor system
Secondary Outcomes
- Total Cholesterol(Change from baseline after 8 week treatments with cranberry and placebo)
- Oxidized LDL (oxLDL)(Change from baseline after 8 week treatments with cranberry and placebo)
- Augmentation Index(Change from baseline after 8 week treatments with cranberry and placebo)
- HDL-C(Change from baseline after 8 week treatments with cranberry and placebo)
- 24-hr Ambulatory Blood Pressure(Change from baseline after 8 week treatments with cranberry and placebo)
- LDL Particle Size(Change from baseline after 8 week treatments with cranberry and placebo)
- LDL-C(Change from baseline after 8 week treatments with cranberry and placebo)
- Malondialdehyde (MDA)(Change from baseline after 8 week treatments with cranberry and placebo)
- High Sensitivity C Reactive Protein (hs-CRP)(Change from baseline after 8 week treatments with cranberry and placebo)
- Efflux capacity of HDL(Change from baseline after 8 week treatments with cranberry and placebo)
- Pulse Wave Velocity(Change from baseline after 8 week treatments with cranberry and placebo)
- Triglycerides(Change from baseline after 8 week treatments with cranberry and placebo)