Cardiovascular Disease Risk FactorsNCT02556749
Effects of Cranberry Juice on Cardiovascular Risk Factors
A study testing Cranberry Juice Beverage in people with Cardiovascular Disease Risk Factors, run by Penn State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Cardiovascular Disease Risk Factors
- What is being tested?
- Cranberry Juice Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cranberry Juice on Cardiovascular Risk Factors in a Placebo-controlled Crossover Trial
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.
Read the 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
- Being tested
- Cranberry Juice Beverage, Placebo Beverage
- Keywords
- Cranberries, blood pressure, cholesterol, SphygmoCor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry Juice BeverageDietary supplement
16 ounces of 54% cranberry juice cocktail
Placebo BeverageDietary supplement
Color, calorie, and taste matched beverage without cranberry bioactives
| Study group | Role | What they receive |
|---|---|---|
| Cranberry Juice Beverage | Experimental | 16 ounces of 54% cranberry juice cocktail Receives: Dietary Supplement: Cranberry Juice Beverage |
| Placebo Beverage | Placebo comparator | Color, calorie, and taste matched beverage without cranberry bioactives Receives: Dietary Supplement: Placebo Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Blood Pressure
Aortic (central) blood pressure measured using the SphygmoCor system
Measured: Change from baseline after 8 week treatments with cranberry and placebo
Peripheral Blood Pressure
Peripheral blood pressure measured using the SphygmoCor system
Measured: Change from baseline after 8 week treatments with cranberry and placebo
Secondary outcomes (12)
Efflux capacity of HDL
Ability to carry out reverse cholesterol transport measured using in vitro assay
Measured: Change from baseline after 8 week treatments with cranberry and placebo
Augmentation Index
Augmentation index measured using the SphygmoCor system
Measured: Change from baseline after 8 week treatments with cranberry and placebo
Pulse Wave Velocity
Pulse wave velocity measured using the SphygmoCor system
Measured: Change from baseline after 8 week treatments with cranberry and placebo
LDL-C
LDL-C values calculated using the Friedewald equation
Measured: Change from baseline after 8 week treatments with cranberry and placebo
LDL Particle Size
LDL particle size measured using a Vertical Auto Profile (VAP) Test
Measured: Change from baseline after 8 week treatments with cranberry and placebo
Total Cholesterol
Total cholesterol values determined by enzymatic procedures
Measured: Change from baseline after 8 week treatments with cranberry and placebo
Triglycerides
Triglyceride values determined using enzymatic procedures
Measured: Change from baseline after 8 week treatments with cranberry and placebo
HDL-C
HDL-C will be estimated according to the modified heparin-manganese procedure
Measured: Change from baseline after 8 week treatments with cranberry and placebo
Oxidized LDL (oxLDL)
Plasma concentrations of oxLDL will be measured using ELISA kits
Measured: Change from baseline after 8 week treatments with cranberry and placebo
Malondialdehyde (MDA)
MDA will be measured using the thiobarbituric acid reactive substances (TBARS) assay
Measured: Change from baseline after 8 week treatments with cranberry and placebo
High Sensitivity C Reactive Protein (hs-CRP)
hs-CRP will be measured by latex-enhanced immunonephelometry
Measured: Change from baseline after 8 week treatments with cranberry and placebo
24-hr Ambulatory Blood Pressure
Measured: Change from baseline after 8 week treatments with cranberry and placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease Risk FactorsStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Ocean Spray Cranberries, Inc.
- Responsible party
- Sponsor
- Investigators
- Penny Kris-Etherton, PhD, RD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556749
- Sponsor's protocol ID
- PKE CRAN
- Status last verified
- Aug 2023
- First submitted
- 18 Sep 2015
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cranberry Juice on Cardiovascular Risk Factors in a Placebo-controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT02556749
- Acronym / sponsor ID
- PKE CRAN
- Conditions
- Cardiovascular Disease Risk Factors
- Keywords
- Cranberries, blood pressure, cholesterol, SphygmoCor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Ocean Spray Cranberries, Inc.
- Study start
- Oct 2015
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry Juice Beverage | Experimental | Dietary Supplement: Cranberry Juice Beverage16 ounces of 54% cranberry juice cocktail |
| Placebo Beverage | Placebo comparator | Dietary Supplement: Placebo BeverageColor, calorie, and taste matched beverage without cranberry bioactives |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranberry Juice Beverage16 ounces of 54% cranberry juice cocktail | Dietary supplement | Cranberry Juice Beverage |
| Placebo BeverageColor, calorie, and taste matched beverage without cranberry bioactives | Dietary supplement | Placebo Beverage |
Primary outcome
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
Peripheral Blood Pressure
Time frame: Change from baseline after 8 week treatments with cranberry and placebo
Peripheral blood pressure measured using the SphygmoCor system
12 secondary outcomes
Efflux capacity of HDL
Time frame: Change from baseline after 8 week treatments with cranberry and placebo
Augmentation Index
Time frame: Change from baseline after 8 week treatments with cranberry and placebo
Pulse Wave Velocity
Time frame: Change from baseline after 8 week treatments with cranberry and placebo
LDL-C
Time frame: Change from baseline after 8 week treatments with cranberry and placebo
LDL Particle Size
Time frame: Change from baseline after 8 week treatments with cranberry and placebo
Total Cholesterol
Time frame: Change from baseline after 8 week treatments with cranberry and placebo
Triglycerides
Time frame: Change from baseline after 8 week treatments with cranberry and placebo
HDL-C
Time frame: Change from baseline after 8 week treatments with cranberry and placebo
Oxidized LDL (oxLDL)
Time frame: Change from baseline after 8 week treatments with cranberry and placebo
Malondialdehyde (MDA)
Time frame: Change from baseline after 8 week treatments with cranberry and placebo
High Sensitivity C Reactive Protein (hs-CRP)
Time frame: Change from baseline after 8 week treatments with cranberry and placebo
24-hr Ambulatory Blood Pressure
Time frame: Change from baseline after 8 week treatments with cranberry and placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penny Kris-Etherton, PhD, RD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry Juice Beverage in people with Cardiovascular Disease Risk Factors, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Blood Pressure (time frame: Change from baseline after 8 week treatments with cranberry and placebo). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.