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

Oklahoma State University

Status: Completed

Conditions: Obesity; Dyslipidemia

Treatments: Dietary Supplement: Freeze-dried strawberries; Dietary Supplement: Dietary fiber

Study type: Interventional

Funder types: Other

Identifiers

NCT01883401

HE1015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 19 to 72 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• on statin therapy
• taking hypoglycemic agents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

High dose strawberry

Experimental group

Description:

50g freeze-dried strawberries/day

Treatment:

Dietary Supplement: Freeze-dried strawberries

Low-dose strawberry

Experimental group

Description:

25g freeze-dried strawberries/day

Treatment:

Dietary Supplement: Freeze-dried strawberries

Fiber/calorie control (high dose)

Other group

Description:

Dietary fiber (8g)

Treatment:

Dietary Supplement: Dietary fiber

Fiber/calorie control (low dose)

Other group

Description:

Dietary fiber (4g)

Treatment:

Dietary Supplement: Dietary fiber