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Effects of Cranberry Juice on Cardiovascular Risk Factors

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ClinicalTrials.gov Identifier: NCT02556749
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Ocean Spray Cranberries, Inc.
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Risk Factors Dietary Supplement: Cranberry Juice Beverage Dietary Supplement: Placebo Beverage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Cranberry Juice on Cardiovascular Risk Factors in a Placebo-controlled Crossover Trial
Study Start Date : October 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556749


Contacts
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Contact: Danette Teeter, BS 814-863-8622

Locations
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United States, Pennsylvania
Penn State CRC Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Danette Teeter, BS    814-863-8622      
Sponsors and Collaborators
Penn State University
Ocean Spray Cranberries, Inc.
Investigators
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Principal Investigator: Penny Kris-Etherton, PhD, RD Penn State University

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Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT02556749     History of Changes
Other Study ID Numbers: PKE CRAN
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Keywords provided by Penny Kris-Etherton, Penn State University:
Cranberries
blood pressure
cholesterol
SphygmoCor
Additional relevant MeSH terms:
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Cardiovascular Diseases