Effects of Freeze Dried Strawberry Powder Supplementation on Cardiovascular Risk Factors and Gut Microbiome

February 13, 2024 updated by: Ann Skulas-Ray, University of Arizona

Effects of Freeze Dried Strawberry Powder Supplementation on Vascular Function, Blood Markers of Cardiovascular Risk, and the Gut Microbiome

Dietary interventions designed to promote health by increasing the consumption of particular health-promoting foods (e.g., strawberries) generally target blood pressure and LDL-C; however, CVD risk reduction may also be achieved via changes in emerging endpoints such as the gut microbiome. Previous research suggests that strawberries have the potential to reduce LDL-C, but it remains unclear whether there is a dose-response relationship. Moreover, few studies have evaluated effects on vascular health or characterized changes in the gut microbiome following daily strawberry consumption. Additionally, previous studies have largely been conducted among Caucasian populations. Given the demographics of the US, it is important to evaluate effects in study populations that include ethnicities that may have higher risk of type 2 diabetes and/or other CVD risk factors, such as Hispanics. This study aims to examine the effects of 4 weeks of supplementation with two doses of freeze dried strawberry powder (low dose: 13 g/d and high dose: 40 g/d) on: 1) LDL-C and blood pressure; 2) gut microbiome profile; and 3) other CVD and type 2 diabetes risk factors, including glucose, insulin, and inflammatory markers. Overweight (BMI 25-36 kg/m2) but otherwise healthy adults with moderately elevated LDL-C (>3.0 mmol/L) and/or prehypertension (120-159/80-99 mm Hg) will be enrolled. This will optimize the potential for observing significant benefits on these outcomes. 50 eligible participants will be recruited with the expectation that at least 40 will complete the study. The placebo-controlled, crossover study design will allow for a direct comparison of dose-response within the same participant. The investigators anticipate that the bioactive components of strawberries will reduce LDL-C and blood pressure, and modify the gut microbiome, with greater changes on the high dose. There is preliminary evidence that polyphenol-rich foods can modify gut microbiota profiles, but this would be the first study to characterize the effects of daily strawberry consumption. The investigators are uniquely placed at the University of Arizona to enroll a larger percentage of Hispanic participants, who are often under-represented in clinical nutritional research. Results from the proposed study will improve understanding of how strawberries might promote health, and could provide further support for the incorporation of whole freeze dried fruit in dietary guidelines.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • University of Arizona

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

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • At least one of the following:

    • LDL-C above 3.0 mmol/L (116 mg/dL)
    • Systolic blood pressure of 120-159 mmHg
    • Diastolic blood pressure of 80-99 mmHg
  • Total cholesterol below 6.2 mmol/L (240 mg/dL)
  • Triglycerides below 350 mg/dL

Exclusion Criteria:

  • Allergies to strawberries
  • History of CVD, Stage II hypertension (BP ≥ 160/100 mmHg), kidney disease, diabetes, or inflammatory diseases such as GI disorders and rheumatoid arthritis
  • Use of medications/supplements for elevated lipids, blood pressure, or glucose
  • Chronic use of non-steroidal anti-inflammatory or immunosuppressant drugs
  • Conditions requiring chronic use of steroids

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
40 g/d placebo powder
Dietary supplement: Placebo powder
40 g/d placebo powder matched for taste and appearance
Experimental: Strawberry powder (high dose)
40 g/d freeze dried strawberry powder
Dietary supplement: Strawberry powder
Freeze dried strawberry powder
Active Comparator: Strawberry powder (low dose)
13 g/d freeze dried strawberry powder
Dietary supplement: Strawberry powder
Freeze dried strawberry powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL-C/non-HDL-C
Time Frame: 4-6 weeks
4-6 weeks
Brachial and central blood pressure
Time Frame: 4-6- weeks
systolic and diastolic blood pressures
4-6- weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse Wave Velocity (PWV)
Time Frame: 4-6 weeks
4-6 weeks
Augmentation Index
Time Frame: 4-6 weeks
augmentation index corrected for heart rate
4-6 weeks
Other lipids and lipoproteins
Time Frame: 4-6 weeks
HDL-C, total cholesterol, and triglycerides
4-6 weeks
Glucose
Time Frame: 4-6 weeks
fasting glucose
4-6 weeks
Insulin
Time Frame: 4-6 weeks
fasting insulin
4-6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiome
Time Frame: 4-6 weeks
Composition of the gut microbial community measured by high-throughput 16S rRNA sequencing
4-6 weeks

Collaborators and Investigators

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

Sponsor

University of Arizona

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 (Actual)

November 1, 2019

Primary Completion (Actual)

March 23, 2021

Study Completion (Actual)

March 23, 2021

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Strawberry Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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