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Completed

NCT Number: NCT01883401

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

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.

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Key information

Age range

19 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • on statin therapy
  • taking hypoglycemic agents

Treatment and study plan

Freeze-dried strawberries

Dietary Supplement

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

Dietary fiber

Dietary Supplement

4g or 8g dietary fiber blended in water

Primary outcomes

  1. Lipids (mg/dL)

    Time frame: 2.5 years

    Change in lipids and lipoproteins at screen and 12 weeks of the study

Secondary outcomes

  1. Adhesion molecules (ng/mL)

    Time frame: 2.5 years

    Change in serum adhesion molecules (ICAM, VCAM) at screen and 12 weeks of the study.

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Collaborators

  • California Strawberry Commission
  • University of Oklahoma

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 21, 2013
Registry last updated
Jun 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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