Skip to main content
OpenTrials
Completed

NCT Number: NCT02556749

Effects of Cranberry Juice on Cardiovascular Risk Factors

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State CRC

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cranberry Juice Beverage

Dietary Supplement

16 ounces of 54% cranberry juice cocktail

Placebo Beverage

Dietary Supplement

Color, calorie, and taste matched beverage without cranberry bioactives

Primary outcomes

  1. 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

  2. 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

  1. Efflux capacity of HDL

    Time frame: Change from baseline after 8 week treatments with cranberry and placebo

    Ability to carry out reverse cholesterol transport measured using in vitro assay

  2. Augmentation Index

    Time frame: Change from baseline after 8 week treatments with cranberry and placebo

    Augmentation index measured using the SphygmoCor system

  3. Pulse Wave Velocity

    Time frame: Change from baseline after 8 week treatments with cranberry and placebo

    Pulse wave velocity measured using the SphygmoCor system

  4. LDL-C

    Time frame: Change from baseline after 8 week treatments with cranberry and placebo

    LDL-C values calculated using the Friedewald equation

  5. LDL Particle Size

    Time frame: Change from baseline after 8 week treatments with cranberry and placebo

    LDL particle size measured using a Vertical Auto Profile (VAP) Test

  6. Total Cholesterol

    Time frame: Change from baseline after 8 week treatments with cranberry and placebo

    Total cholesterol values determined by enzymatic procedures

  7. Triglycerides

    Time frame: Change from baseline after 8 week treatments with cranberry and placebo

    Triglyceride values determined using enzymatic procedures

  8. HDL-C

    Time frame: Change from baseline after 8 week treatments with cranberry and placebo

    HDL-C will be estimated according to the modified heparin-manganese procedure

  9. Oxidized LDL (oxLDL)

    Time frame: Change from baseline after 8 week treatments with cranberry and placebo

    Plasma concentrations of oxLDL will be measured using ELISA kits

  10. Malondialdehyde (MDA)

    Time frame: Change from baseline after 8 week treatments with cranberry and placebo

    MDA will be measured using the thiobarbituric acid reactive substances (TBARS) assay

  11. High Sensitivity C Reactive Protein (hs-CRP)

    Time frame: Change from baseline after 8 week treatments with cranberry and placebo

    hs-CRP will be measured by latex-enhanced immunonephelometry

  12. 24-hr Ambulatory Blood Pressure

    Time frame: Change from baseline after 8 week treatments with cranberry and placebo

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Ocean Spray Cranberries, Inc.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2015
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.