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

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ClinicalTrials.gov Identifier: NCT02557334
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
California Strawberry Commission
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: Low Dose Strawberry Powder Dietary Supplement: High Dose Strawberry Powder Dietary Supplement: Placebo Powder Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Freeze Dried Strawberry Powder Supplementation on Vascular Function and Blood Markers of Cardiovascular Risk
Study Start Date : October 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557334


Contacts
Contact: Danette Teeter, BS 814-863-8622

Locations
United States, Pennsylvania
Penn State CRC Recruiting
University Park, Pennsylvania, United States, 16803
Contact: Danette Teeter, BS    814-863-8622      
Sponsors and Collaborators
Penn State University
California Strawberry Commission
Investigators
Principal Investigator: Penny Kris-Etherton, PhD, RD Penn State University

Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT02557334     History of Changes
Other Study ID Numbers: PKE STRAW II
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Keywords provided by Penny Kris-Etherton, Penn State University:
Strawberry Powder
Cardiovascular Disease Risk Factors

Additional relevant MeSH terms:
Cardiovascular Diseases