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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883401
• Other study ID #: HE1015
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: June 19, 2013
• Start date: April 2010
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: Oklahoma State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 72 Years

Eligibility

Inclusion Criteria:

• dyslipidemia

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

Exclusion Criteria:

• on statin therapy

• taking hypoglycemic agents

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Obesity

Intervention

Dietary Supplement:
• Freeze-dried strawberries
25g or 50g freeze-dried strawberries reconstituted in water
• Dietary fiber
4g or 8g dietary fiber blended in water

Locations

Country	Name	City	State
United States	Oklahoma State University	Stillwater	Oklahoma

Sponsors (3)

Lead Sponsor	Collaborator
Oklahoma State University	California Strawberry Commission, University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (1)

Basu A, Fu DX, Wilkinson M, Simmons B, Wu M, Betts NM, Du M, Lyons TJ. Strawberries decrease atherosclerotic markers in subjects with metabolic syndrome. Nutr Res. 2010 Jul;30(7):462-9. doi: 10.1016/j.nutres.2010.06.016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipids (mg/dL)	Change in lipids and lipoproteins at screen and 12 weeks of the study	2.5 years	No
Secondary	Adhesion molecules (ng/mL)	Change in serum adhesion molecules (ICAM, VCAM) at screen and 12 weeks of the study.	2.5 years	No