Effects of Freeze Dried Strawberry Powder Supplementation on Vascular Function and Blood Markers of Cardiovascular Risk

August 15, 2023 updated by: Penn State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16803
        • Penn State CRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women 35-65 years of age
  2. BMI ≥ 25 and ≤ 39 kg/m^2
  3. LDL-C > 116 mg/dL
  4. Total Cholesterol below 273 mg/dL for men and below 284 mg/dL for women
  5. Triglycerides below 350 mg/d
  6. Non-smokers
  7. Blood pressure < 160/100 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 the 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 strawberries or any ingredient in the study powders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Dose Strawberry Powder
40 g composed of 13 g freeze dried strawberry powder + 27 g placebo powder
Dietary supplement: Low Dose Strawberry Powder
40 g composed of 13 g freeze dried strawberry powder + 27 g placebo powder
Experimental: High Dose Strawberry Powder
40 g freeze dried strawberry powder
Dietary supplement: High Dose Strawberry Powder
40 g freeze dried strawberry powder
Placebo Comparator: Placebo Powder
40 g color and taste matched placebo powder
Dietary supplement: Placebo Powder
40 g color and taste matched placebo powder

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Central Blood Pressure
Time Frame: Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Aortic (central) blood pressure measured using the SphygmoCor System
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
Peripheral blood pressure measured using the SphygmoCor System
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
Augmentation index measured using the SphygmoCor System
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
Pulse wave velocity measured using the SphygmoCor System
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
Total cholesterol values determined by enzymatic procedures
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
Triglyceride values determined using enzymatic procedures
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
HDL-C will be estimated according to the modified heparin-manganese procedure
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
Plasma concentrations of oxLDL will be measured using ELISA kits
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
MDA will be measured using the thiobarbituric acid reactive substances (TBARS) assay
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
hs-CRP will be measured by latex-enhanced immunonephelometry
Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
California Strawberry Commission

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Penny Kris-Etherton, PhD, RD, Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PKE STRAW II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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