Effects of Cranberry Juice on Cardiovascular Risk Factors

NCT02556749 | Completed

• 1 other identifier: PKE CRAN
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease Risk Factors

Keywords

Cranberries; blood pressure; cholesterol; SphygmoCor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Efflux capacity of HDL

  Change from baseline after 8 week treatments with cranberry and placebo

• Augmentation Index

  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

• LDL-C

  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

Study Arms (2)

Cranberry Juice Beverage

EXPERIMENTAL

16 ounces of 54% cranberry juice cocktail

Dietary Supplement: Cranberry Juice Beverage

Placebo Beverage

PLACEBO COMPARATOR

Color, calorie, and taste matched beverage without cranberry bioactives

Dietary Supplement: Placebo Beverage

Interventions

Cranberry Juice Beverage DIETARY_SUPPLEMENT

16 ounces of 54% cranberry juice cocktail

Cranberry Juice Beverage

Placebo Beverage DIETARY_SUPPLEMENT

Color, calorie, and taste matched beverage without cranberry bioactives

Placebo Beverage

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• Ocean Spray Cranberries, Inc.: collaborator

Study Sites (1)

Penn State CRC

University Park, Pennsylvania, 16802, United States

Location

Study Officials

• Penny Kris-Etherton, PhD, RD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 22, 2015
• Study Start: October 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

US (1)