Cardiovascular DiseaseNCT02557334
Effects of Freeze Dried Strawberry Powder Supplementation on Vascular Function and Blood Markers of Cardiovascular Risk
A study testing Low Dose Strawberry Powder and High Dose Strawberry Powder in people with Cardiovascular Disease, run by Penn State University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of freeze dried strawberry powder on LDL cholesterol, central and peripheral blood pressure, indices of arterial stiffness, and other lipid and lipoprotein concentrations. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Low Dose Strawberry Powder and High Dose Strawberry Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 35-65 years of age
- BMI ≥ 25 and ≤ 39 kg/m^2
- LDL-C > 116 mg/dL
- Total Cholesterol below 273 mg/dL for men and below 284 mg/dL for women
- Triglycerides below 350 mg/d
- Non-smokers
- Blood pressure < 160/100 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 the 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
Show all 11Show fewer
- 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 strawberries or any ingredient in the study powders
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effects of freeze dried strawberry powder on LDL cholesterol, central and peripheral blood pressure, indices of arterial stiffness, and other lipid and lipoprotein concentrations. The investigators hypothesize that the bioactive compounds in freeze dried strawberry powder may elicit beneficial effects on LDL cholesterol, as well as blood pressure and arterial health.
Read the detailed description
The proposed study design is a 3-period randomized crossover dose-response study to evaluate the effect of freeze dried strawberry powder supplementation on LDL-C and vascular health. Research participants will be overweight or obese (BMI 25-39 kg/m^2) but otherwise healthy adults with moderately elevated LDL-C (>116 mg/dL or >3.0mmol/L), blood pressure <160/100 mmHg, total cholesterol below 273 mg/dL for men and below 284 mg/dL for women, and triglycerides below 350 mg/dL. Subjects will be randomly assigned to three supplementation periods: 1) low dose freeze dried strawberry powder (13 g/d); 2) high dose freeze dried strawberry powder (40 g/d); and 3) a placebo powder. Each powder will be provided for 4-6 weeks, separated by a 2-week washout period between treatment periods. Baseline and endpoint testing will include blood collection and vascular testing.
- Conditions
- Cardiovascular Disease
- Being tested
- Low Dose Strawberry Powder, High Dose Strawberry Powder, Placebo Powder
- Keywords
- Strawberry Powder, Cardiovascular Disease Risk Factors
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Strawberry PowderDietary supplement
40 g composed of 13 g freeze dried strawberry powder + 27 g placebo powder
High Dose Strawberry PowderDietary supplement
40 g freeze dried strawberry powder
Placebo PowderDietary supplement
40 g color and taste matched placebo powder
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Strawberry Powder | Experimental | 40 g composed of 13 g freeze dried strawberry powder + 27 g placebo powder Receives: Dietary Supplement: Low Dose Strawberry Powder |
| High Dose Strawberry Powder | Experimental | 40 g freeze dried strawberry powder Receives: Dietary Supplement: High Dose Strawberry Powder |
| Placebo Powder | Placebo comparator | 40 g color and taste matched placebo powder Receives: Dietary Supplement: Placebo Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C
LDL-C values calculated using the Friedewald equation
Measured: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Secondary outcomes (10)
Central Blood Pressure
Aortic (central) blood pressure measured using the SphygmoCor System
Measured: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Peripheral Blood Pressure
Peripheral blood pressure measured using the SphygmoCor System
Measured: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Augmentation Index
Augmentation index measured using the SphygmoCor System
Measured: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Pulse Wave Velocity
Pulse wave velocity measured using the SphygmoCor System
Measured: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Total Cholesterol
Total cholesterol values determined by enzymatic procedures
Measured: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Triglycerides
Triglyceride values determined using enzymatic procedures
Measured: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
HDL-C
HDL-C will be estimated according to the modified heparin-manganese procedure
Measured: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Oxidized LDL (oxLDL)
Plasma concentrations of oxLDL will be measured using ELISA kits
Measured: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Malondialdehyde (MDA)
MDA will be measured using the thiobarbituric acid reactive substances (TBARS) assay
Measured: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
High Sensitivity C Reactive Protein (hs-CRP)
hs-CRP will be measured by latex-enhanced immunonephelometry
Measured: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 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 DiseaseStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- California Strawberry Commission
- Responsible party
- Sponsor
- Investigators
- Penny Kris-Etherton, PhD, RD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557334
- Sponsor's protocol ID
- PKE STRAW II
- 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 Freeze Dried Strawberry Powder Supplementation on Vascular Function and Blood Markers of Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT02557334
- Acronym / sponsor ID
- PKE STRAW II
- Conditions
- Cardiovascular Disease
- Keywords
- Strawberry Powder, Cardiovascular Disease Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- California Strawberry Commission
- Study start
- Oct 2015 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 23 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 freeze dried strawberry powder on LDL cholesterol, central and peripheral blood pressure, indices of arterial stiffness, and other lipid and lipoprotein concentrations. The investigators hypothesize that the bioactive compounds in freeze dried strawberry powder may elicit beneficial effects on LDL cholesterol, as well as blood pressure and arterial health.
Detailed description
The proposed study design is a 3-period randomized crossover dose-response study to evaluate the effect of freeze dried strawberry powder supplementation on LDL-C and vascular health. Research participants will be overweight or obese (BMI 25-39 kg/m^2) but otherwise healthy adults with moderately elevated LDL-C (>116 mg/dL or >3.0mmol/L), blood pressure <160/100 mmHg, total cholesterol below 273 mg/dL for men and below 284 mg/dL for women, and triglycerides below 350 mg/dL. Subjects will be randomly assigned to three supplementation periods: 1) low dose freeze dried strawberry powder (13 g/d); 2) high dose freeze dried strawberry powder (40 g/d); and 3) a placebo powder. Each powder will be provided for 4-6 weeks, separated by a 2-week washout period between treatment periods. Baseline and endpoint testing will include blood collection and vascular testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose Strawberry Powder | Experimental | Dietary Supplement: Low Dose Strawberry Powder40 g composed of 13 g freeze dried strawberry powder + 27 g placebo powder |
| High Dose Strawberry Powder | Experimental | Dietary Supplement: High Dose Strawberry Powder40 g freeze dried strawberry powder |
| Placebo Powder | Placebo comparator | Dietary Supplement: Placebo Powder40 g color and taste matched placebo powder |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women 35-65 years of age
- BMI ≥ 25 and ≤ 39 kg/m^2
- LDL-C > 116 mg/dL
- Total Cholesterol below 273 mg/dL for men and below 284 mg/dL for women
- Triglycerides below 350 mg/d
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 the 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 |
|---|---|---|
| Low Dose Strawberry Powder40 g composed of 13 g freeze dried strawberry powder + 27 g placebo powder | Dietary supplement | Low Dose Strawberry Powder |
| High Dose Strawberry Powder40 g freeze dried strawberry powder | Dietary supplement | High Dose Strawberry Powder |
| Placebo Powder40 g color and taste matched placebo powder | Dietary supplement | Placebo Powder |
Primary outcome
LDL-C
Time frame: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
LDL-C values calculated using the Friedewald equation
10 secondary outcomes
Central Blood Pressure
Time frame: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Peripheral Blood Pressure
Time frame: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Augmentation Index
Time frame: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Pulse Wave Velocity
Time frame: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Total Cholesterol
Time frame: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Triglycerides
Time frame: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
HDL-C
Time frame: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Oxidized LDL (oxLDL)
Time frame: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Malondialdehyde (MDA)
Time frame: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
High Sensitivity C Reactive Protein (hs-CRP)
Time frame: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
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 Low Dose Strawberry Powder and High Dose Strawberry Powder in people with Cardiovascular Disease, 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 7 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?
LDL-C (time frame: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage). 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.