Trial | NCT01883401  Report issue

Title

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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fiber strawberry ...

  • Study Participants

    60
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.
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.
Study Started
Apr 30
2010
Primary Completion
Mar 31
2013
Study Completion
Mar 31
2013
Last Update
Jun 21
2013
Estimate

Dietary Supplement Freeze-dried strawberries

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

Dietary Supplement Dietary fiber

4g or 8g dietary fiber blended in water

High dose strawberry Experimental

50g freeze-dried strawberries/day

Low-dose strawberry Experimental

25g freeze-dried strawberries/day

Fiber/calorie control (high dose) Other

Dietary fiber (8g)

Fiber/calorie control (low dose) Other

Dietary fiber (4g)

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

on statin therapy
taking hypoglycemic agents
No Results Posted