Effects of Cranberry Juice on Cardiovascular Risk Factors

Effects of Cranberry Juice on Cardiovascular Risk Factors in a Placebo-controlled Crossover Trial

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease Risk Factors
• Intervention / Treatment: Dietary supplement: Cranberry Juice Beverage; Dietary supplement: Placebo Beverage

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Penn State CRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cranberry Juice Beverage; 16 ounces of 54% cranberry juice cocktail	Dietary supplement: Cranberry Juice Beverage; 16 ounces of 54% cranberry juice cocktail
Placebo Comparator: Placebo Beverage; Color, calorie, and taste matched beverage without cranberry bioactives	Dietary supplement: Placebo Beverage; Color, calorie, and taste matched beverage without cranberry bioactives

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Blood Pressure	Aortic (central) blood pressure measured using the SphygmoCor system	Change from baseline after 8 week treatments with cranberry and placebo
Peripheral Blood Pressure	Peripheral blood pressure measured using the SphygmoCor system	Change from baseline after 8 week treatments with cranberry and placebo

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efflux capacity of HDL	Ability to carry out reverse cholesterol transport measured using in vitro assay	Change from baseline after 8 week treatments with cranberry and placebo
Augmentation Index	Augmentation index measured using the SphygmoCor system	Change from baseline after 8 week treatments with cranberry and placebo
Pulse Wave Velocity	Pulse wave velocity measured using the SphygmoCor system	Change from baseline after 8 week treatments with cranberry and placebo
LDL-C	LDL-C values calculated using the Friedewald equation	Change from baseline after 8 week treatments with cranberry and placebo
LDL Particle Size	LDL particle size measured using a Vertical Auto Profile (VAP) Test	Change from baseline after 8 week treatments with cranberry and placebo
Total Cholesterol	Total cholesterol values determined by enzymatic procedures	Change from baseline after 8 week treatments with cranberry and placebo
Triglycerides	Triglyceride values determined using enzymatic procedures	Change from baseline after 8 week treatments with cranberry and placebo
HDL-C	HDL-C will be estimated according to the modified heparin-manganese procedure	Change from baseline after 8 week treatments with cranberry and placebo
Oxidized LDL (oxLDL)	Plasma concentrations of oxLDL will be measured using ELISA kits	Change from baseline after 8 week treatments with cranberry and placebo
Malondialdehyde (MDA)	MDA will be measured using the thiobarbituric acid reactive substances (TBARS) assay	Change from baseline after 8 week treatments with cranberry and placebo
High Sensitivity C Reactive Protein (hs-CRP)	hs-CRP will be measured by latex-enhanced immunonephelometry	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

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: Ocean Spray Cranberries, Inc.
• Investigators: Principal Investigator: Penny Kris-Etherton, PhD, RD, Penn State University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: September 21, 2015
• First Posted (Estimated): September 22, 2015

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: blood pressure; cholesterol; Cranberries; SphygmoCor
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: PKE CRAN