Clinical trial NCT02556749: Effects of Cranberry Juice on Cardiovascular Risk Factors
Official title: Effects of Cranberry Juice on Cardiovascular Risk Factors in a Placebo-controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease Risk Factors
Keywords: Cranberries
blood pressure
cholesterol
SphygmoCor
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Ocean Spray Cranberries, Inc.
First posted: 2015-09-22
Enrollment: 47
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Central Blood Pressure
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
measure: Peripheral Blood Pressure
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
Secondary outcomes:
measure: Efflux capacity of HDL
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
measure: Augmentation Index
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
measure: Pulse Wave Velocity
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
measure: LDL-C
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
measure: LDL Particle Size
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
measure: Total Cholesterol
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
measure: Triglycerides
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
measure: HDL-C
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
measure: Oxidized LDL (oxLDL)
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
measure: Malondialdehyde (MDA)
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
measure: High Sensitivity C Reactive Protein (hs-CRP)
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
measure: 24-hr Ambulatory Blood Pressure
timeFrame: Change from baseline after 8 week treatments with cranberry and placebo
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State CRC
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny Kris-Etherton, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: