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Chronic Effects of Freeze-Dried Strawberry Beverage on Cardiovascular Risk Factors

Chronic Effects of Freeze-dried Strawberry Beverage on Cardiovascular Risk Factors in Subjects With Abdominal Adiposity and Dyslipidemia.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01883401
Enrollment
60
Registered
2013-06-21
Start date
2010-04-30
Completion date
2013-03-31
Last updated
2013-06-21

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

Conditions

Dyslipidemia, Obesity

Keywords

Strawberries, Heart health, Anthocyanins

Brief summary

Berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia while no such studies with whole strawberries have been reported in the US population. The investigators propose to examine the effects of low and high doses of freeze-dried strawberries on serum glucose, insulin, and lipid profile, biomarkers of oxidative stress and inflammation, in a 12-week randomized controlled trial. Subjects with abdominal adiposity and dyslipidemia (n=15/group) will be recruited at OUHSC and OSU, and randomly assigned to the low (25g/day) or high (50g/day) strawberry dose, or matched control (fiber and calories) group. The strawberry group will consume freeze-dried strawberry beverage (2 cups/day) and the controls will consume 2 cups beverage (fiber +calories) daily for 12 weeks. Blood draws, anthropometrics, blood pressure, and dietary data will be collected at screen, 6 and 12 weeks of the study to determine chronic and acute effects of strawberry intervention. Serum or plasma samples will be analyzed for fasting glucose, insulin, lipid profile including total cholesterol, LDL-, and HDL-cholesterol, triglycerides, lipid particle size, and levels of oxidative stress (malondialdehyde, oxidized LDL, myeloperoxidase), inflammation (high sensitivity C-reactive protein, adiponectin, interleukins) and adhesion molecules. Repeated measures ANOVA will be performed using a 5% significance level. We anticipate a dose response effect in decrease in lipids, oxidative stress or inflammation following strawberry intervention versus controls.

Detailed description

The overall objective of this clinical trial is to investigate the effects of low and high doses of freeze-dried strawberries in cardiovascular risk factors in subjects with abdominal adiposity and dyslipidemia versus age and gender-matched controls.

Interventions

DIETARY_SUPPLEMENTFreeze-dried strawberries

25g or 50g freeze-dried strawberries reconstituted in water

DIETARY_SUPPLEMENTDietary fiber

4g or 8g dietary fiber blended in water

Sponsors

University of Oklahoma
CollaboratorOTHER
California Strawberry Commission
CollaboratorOTHER
Oklahoma State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
19 Years to 72 Years
Healthy volunteers
No

Inclusion criteria

* dyslipidemia * abdominal adiposity (\>35 inches for women, \>40 inches for men)

Exclusion criteria

* on statin therapy * taking hypoglycemic agents

Design outcomes

Primary

MeasureTime frameDescription
Lipids (mg/dL)2.5 yearsChange in lipids and lipoproteins at screen and 12 weeks of the study

Secondary

MeasureTime frameDescription
Adhesion molecules (ng/mL)2.5 yearsChange in serum adhesion molecules (ICAM, VCAM) at screen and 12 weeks of the study.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026