Effects of Cranberry Juice on Cardiovascular Risk Factors

Not Applicable

Completed

• Conditions: Cardiovascular Disease Risk Factors
• Interventions: Dietary Supplement: Placebo Beverage; Dietary Supplement: Cranberry Juice Beverage

• Registration Number: NCT02556749
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Study Start: 2015-10
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Beverage	Placebo Beverage	Color, calorie, and taste matched beverage without cranberry bioactives
Cranberry Juice Beverage	Cranberry Juice Beverage	16 ounces of 54% cranberry juice cocktail

Primary Outcome Measures

Name	Time	Method
Central Blood Pressure	Change from baseline after 8 week treatments with cranberry and placebo	Aortic (central) blood pressure measured using the SphygmoCor system
Peripheral Blood Pressure	Change from baseline after 8 week treatments with cranberry and placebo	Peripheral blood pressure measured using the SphygmoCor system

Secondary Outcome Measures

Name	Time	Method
Malondialdehyde (MDA)	Change from baseline after 8 week treatments with cranberry and placebo	MDA will be measured using the thiobarbituric acid reactive substances (TBARS) assay
High Sensitivity C Reactive Protein (hs-CRP)	Change from baseline after 8 week treatments with cranberry and placebo	hs-CRP will be measured by latex-enhanced immunonephelometry
Total Cholesterol	Change from baseline after 8 week treatments with cranberry and placebo	Total cholesterol values determined by enzymatic procedures
Oxidized LDL (oxLDL)	Change from baseline after 8 week treatments with cranberry and placebo	Plasma concentrations of oxLDL will be measured using ELISA kits
Augmentation Index	Change from baseline after 8 week treatments with cranberry and placebo	Augmentation index measured using the SphygmoCor system
HDL-C	Change from baseline after 8 week treatments with cranberry and placebo	HDL-C will be estimated according to the modified heparin-manganese procedure
24-hr Ambulatory Blood Pressure	Change from baseline after 8 week treatments with cranberry and placebo
Efflux capacity of HDL	Change from baseline after 8 week treatments with cranberry and placebo	Ability to carry out reverse cholesterol transport measured using in vitro assay
Pulse Wave Velocity	Change from baseline after 8 week treatments with cranberry and placebo	Pulse wave velocity measured using the SphygmoCor system
LDL-C	Change from baseline after 8 week treatments with cranberry and placebo	LDL-C values calculated using the Friedewald equation
LDL Particle Size	Change from baseline after 8 week treatments with cranberry and placebo	LDL particle size measured using a Vertical Auto Profile (VAP) Test
Triglycerides	Change from baseline after 8 week treatments with cranberry and placebo	Triglyceride values determined using enzymatic procedures

Trial Locations

Locations (1)

Penn State CRC; 🇺🇸 University Park, Pennsylvania, United States