Effect of Strawberries on Cardiovascular Disease Risk

August 16, 2023 updated by: Penn State University

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

It is important to identify and evaluate foods, such as strawberries, that can improve established and emerging cardiovascular risk factors, such as postprandial lipid and glycemic responses, and vascular health. Postprandial derangements may affect multiple metabolic pathways that lead to increased arterial stiffness. Research has demonstrated the potential of strawberries to ameliorate postprandial responses to a high fat/high glucose meal. Further research is needed to demonstrate this effect in better controlled clinical studies and explore whether metabolic effects lead to improved arterial health.

The investigators propose to examine the effects of adding 40 g of freeze-dried strawberry powder to a high fat/high glucose meal on postprandial cardiovascular risk factor including lipids, insulin, glucose, and arterial stiffness and central blood pressure. The investigators hypothesize that the bioactive components of strawberry powder will attenuate postprandial lipemic and glycemic responses, as well as improve measures of arterial health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • 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, 16801
        • Penn State University

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

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 20-50 years of age
  • LDL-C below 160 mg/dL
  • Triglycerides below 350 mg/dL
  • No stage II hypertension (BP below 160/100 mmHg)
  • Not taking medication for elevated lipids, blood pressure, or glucose

Exclusion Criteria:

  • Allergies to strawberries
  • Known intolerance to high fat meals
  • History of cardiovascular disease, kidney disease, diabetes or inflammatory diseases such as GI disorders and arthritis
  • Use of non-steroidal anti-inflammatory or immunosuppressant drugs
  • Conditions requiring the use of steroids
  • Use of medication or supplements for elevated lipids, blood pressure or glucose

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strawberry Meal
40 g freeze-dried strawberries included in test meal
Dietary supplement: Strawberry Meal
High-fat meal (50 g total fat) with 40 g freeze dried strawberry powder
Placebo Comparator: Control Meal
Control consisting of matched test meal with strawberry flavoring instead of freeze-dried strawberry powder
Dietary supplement: Control Meal
High-fat meal (50 g total fat) with a matched placebo powder containing no strawberry bioactives

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in postprandial central blood pressure and arterial stiffness
Time Frame: 2 and 4 hours
2 and 4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Postprandial changes in insulin
Time Frame: 0, 0.5, 1, 2, and 4 hours
0, 0.5, 1, 2, and 4 hours
Postprandial changes in glucose
Time Frame: 0, 0.5, 1, 2, and 4 hours
0, 0.5, 1, 2, and 4 hours
Postprandial changes in markers of inflammation/oxidative stress
Time Frame: 0, 0.5, 1, 2, and 4 hours
0, 0.5, 1, 2, and 4 hours
Change from baseline in postprandial triglycerides at 0.5, 1, 2, and 4 hours
Time Frame: 0.5, 1, 2, and 4 hours
0.5, 1, 2, and 4 hours

Collaborators and Investigators

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

Sponsor

Penn State University

Collaborators

California Strawberry Commission

Investigators

  • Principal Investigator: Penny M Kris-Etherton, PhD, The Pennsylvania State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimated)

November 21, 2013

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKE STR

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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