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

Not Applicable
Completed
Conditions
Dyslipidemia
Obesity
Interventions
Dietary Supplement: Freeze-dried strawberries
Dietary Supplement: Dietary fiber
Registration Number
NCT01883401
Lead Sponsor
Oklahoma State University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • dyslipidemia
  • abdominal adiposity (>35 inches for women, >40 inches for men)
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Exclusion Criteria
  • on statin therapy
  • taking hypoglycemic agents
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
High dose strawberryFreeze-dried strawberries50g freeze-dried strawberries/day
Low-dose strawberryFreeze-dried strawberries25g freeze-dried strawberries/day
Fiber/calorie control (high dose)Dietary fiberDietary fiber (8g)
Fiber/calorie control (low dose)Dietary fiberDietary fiber (4g)
Primary Outcome Measures
NameTimeMethod
Lipids (mg/dL)2.5 years

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

Secondary Outcome Measures
NameTimeMethod
Adhesion molecules (ng/mL)2.5 years

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

Trial Locations

Locations (1)

Oklahoma State University

🇺🇸

Stillwater, Oklahoma, United States

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