Effects of Cranberry Juice on Cardiovascular Risk Factors

Cardiovascular Disease Risk Factors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556749
• Other study ID #: PKE CRAN
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: May 2019

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease Risk Factors
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Cranberry Juice Beverage
16 ounces of 54% cranberry juice cocktail
• Placebo Beverage
Color, calorie, and taste matched beverage without cranberry bioactives

Locations

Country	Name	City	State
United States	Penn State CRC	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Ocean Spray Cranberries, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Blood Pressure	Aortic (central) blood pressure measured using the SphygmoCor system	Change from baseline after 8 week treatments with cranberry and placebo
Primary	Peripheral Blood Pressure	Peripheral blood pressure measured using the SphygmoCor system	Change from baseline after 8 week treatments with cranberry and placebo
Secondary	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
Secondary	Augmentation Index	Augmentation index measured using the SphygmoCor system	Change from baseline after 8 week treatments with cranberry and placebo
Secondary	Pulse Wave Velocity	Pulse wave velocity measured using the SphygmoCor system	Change from baseline after 8 week treatments with cranberry and placebo
Secondary	LDL-C	LDL-C values calculated using the Friedewald equation	Change from baseline after 8 week treatments with cranberry and placebo
Secondary	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
Secondary	Total Cholesterol	Total cholesterol values determined by enzymatic procedures	Change from baseline after 8 week treatments with cranberry and placebo
Secondary	Triglycerides	Triglyceride values determined using enzymatic procedures	Change from baseline after 8 week treatments with cranberry and placebo
Secondary	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
Secondary	Oxidized LDL (oxLDL)	Plasma concentrations of oxLDL will be measured using ELISA kits	Change from baseline after 8 week treatments with cranberry and placebo
Secondary	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
Secondary	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
Secondary	24-hr Ambulatory Blood Pressure		Change from baseline after 8 week treatments with cranberry and placebo