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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03522974
Enrollment
1
Registered
2018-05-14
Start date
2019-11-01
Completion date
2021-03-23
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTStrawberry powder

Freeze dried strawberry powder

DIETARY_SUPPLEMENTPlacebo powder

40 g/d placebo powder matched for taste and appearance

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Brachial and central blood pressure4-6- weekssystolic and diastolic blood pressures
LDL-C/non-HDL-C4-6 weeks

Secondary

MeasureTime frameDescription
Augmentation Index4-6 weeksaugmentation index corrected for heart rate
Other lipids and lipoproteins4-6 weeksHDL-C, total cholesterol, and triglycerides
Insulin4-6 weeksfasting insulin
Glucose4-6 weeksfasting glucose
Pulse Wave Velocity (PWV)4-6 weeks

Other

MeasureTime frameDescription
Gut microbiome4-6 weeksComposition of the gut microbial community measured by high-throughput 16S rRNA sequencing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026