Effects of Cranberry Juice on Cardiovascular Risk Factors

NCT ID: NCT02556749

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2019-05-31

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.

Conditions

Cardiovascular Disease Risk Factors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Cranberry Juice Beverage

16 ounces of 54% cranberry juice cocktail

Group Type: EXPERIMENTAL

Cranberry Juice Beverage

Intervention Type: DIETARY_SUPPLEMENT

16 ounces of 54% cranberry juice cocktail

Placebo Beverage

Color, calorie, and taste matched beverage without cranberry bioactives

Group Type: PLACEBO_COMPARATOR

Placebo Beverage

Intervention Type: DIETARY_SUPPLEMENT

Color, calorie, and taste matched beverage without cranberry bioactives

Interventions

Cranberry Juice Beverage

16 ounces of 54% cranberry juice cocktail

Intervention Type: DIETARY_SUPPLEMENT

Placebo Beverage

Color, calorie, and taste matched beverage without cranberry bioactives

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ocean Spray Cranberries, Inc.

INDUSTRY

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Penny Kris-Etherton, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Penn State CRC

University Park, Pennsylvania, United States

Countries

United States

Other Identifiers

PKE CRAN

Identifier Type: -

Identifier Source: org_study_id