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

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University of Arizona

Status

Terminated

Conditions

Cardiovascular Risk Factor

Treatments

Dietary Supplement: Strawberry powder
Dietary Supplement: Placebo powder

Study type

Interventional

Funder types

Other

Identifiers

NCT03522974
Strawberry Study

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

1 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
40 g/d placebo powder
Treatment:
Dietary Supplement: Placebo powder
Strawberry powder (high dose)
Experimental group
Description:
40 g/d freeze dried strawberry powder
Treatment:
Dietary Supplement: Strawberry powder
Strawberry powder (low dose)
Active Comparator group
Description:
13 g/d freeze dried strawberry powder
Treatment:
Dietary Supplement: Strawberry powder

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Chesney Richter, PhD; Ann Skulas-Ray, PhD

Data sourced from clinicaltrials.gov

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