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.

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Dyslipidemia
• Intervention / Treatment: Dietary supplement: Freeze-dried strawberries; Dietary supplement: Dietary fiber

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Stillwater, Oklahoma, United States, 74078
      • Oklahoma State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• on statin therapy
• taking hypoglycemic agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High dose strawberry; 50g freeze-dried strawberries/day	Dietary supplement: Freeze-dried strawberries; 25g or 50g freeze-dried strawberries reconstituted in water
Experimental: Low-dose strawberry; 25g freeze-dried strawberries/day	Dietary supplement: Freeze-dried strawberries; 25g or 50g freeze-dried strawberries reconstituted in water
Other: Fiber/calorie control (high dose); Dietary fiber (8g)	Dietary supplement: Dietary fiber; 4g or 8g dietary fiber blended in water
Other: Fiber/calorie control (low dose); Dietary fiber (4g)	Dietary supplement: Dietary fiber; 4g or 8g dietary fiber blended in water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipids (mg/dL)	Change in lipids and lipoproteins at screen and 12 weeks of the study	2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adhesion molecules (ng/mL)	Change in serum adhesion molecules (ICAM, VCAM) at screen and 12 weeks of the study.	2.5 years

Collaborators and Investigators

• Sponsor: Oklahoma State University
• Collaborators: University of Oklahoma; California Strawberry Commission
• Investigators: Principal Investigator: Arpita Basu, Phd, Oklahoma State University

Publications and helpful links

General Publications

• 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.
• Basu A, Betts NM, Nguyen A, Newman ED, Fu D, Lyons TJ. Freeze-dried strawberries lower serum cholesterol and lipid peroxidation in adults with abdominal adiposity and elevated serum lipids. J Nutr. 2014 Jun;144(6):830-7. doi: 10.3945/jn.113.188169. Epub 2014 Mar 26.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: June 19, 2013
• First Posted (Estimate): June 21, 2013

Study Record Updates

• Last Update Posted (Estimate): June 21, 2013
• Last Update Submitted That Met QC Criteria: June 19, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Anthocyanins; Strawberries; Heart health
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: HE1015