Effects of Freeze Dried Strawberry Powder Supplementation on Vascular Function and Blood Markers of Cardiovascular Risk

The proposed study design is a 3-period randomized crossover dose-response study to evaluate the effect of freeze dried strawberry powder supplementation on LDL-C and vascular health. Research participants will be overweight or obese (BMI 25-39 kg/m^2) but otherwise healthy adults with moderately elevated LDL-C (>116 mg/dL or >3.0mmol/L), blood pressure <160/100 mmHg, total cholesterol below 273 mg/dL for men and below 284 mg/dL for women, and triglycerides below 350 mg/dL. Subjects will be randomly assigned to three supplementation periods: 1) low dose freeze dried strawberry powder (13 g/d); 2) high dose freeze dried strawberry powder (40 g/d); and 3) a placebo powder. Each powder will be provided for 4-6 weeks, separated by a 2-week washout period between treatment periods. Baseline and endpoint testing will include blood collection and vascular testing.

Inclusion criteria

• Men and women 35-65 years of age
• BMI ≥ 25 and ≤ 39 kg/m^2
• LDL-C > 116 mg/dL
• Total Cholesterol below 273 mg/dL for men and below 284 mg/dL for women
• Triglycerides below 350 mg/d
• Non-smokers
• Blood pressure < 160/100 mmHg

Exclusion criteria

• History of acute or chronic inflammatory conditions or heart disease, kidney disease, liver disease, autoimmune disorders, or thyroid disease (unless controlled by medication and blood results within the previous 6 months are provided)
• History of diabetes mellitus (and/or a fasting glucose > 126 mg/dL at screening)
• Stage II hypertension (blood pressure ≥ 160/100 mmHg)
• Lactation, pregnancy, or desire to become pregnant during the study
• Unwillingness to discontinue nutritional supplements, herbs, or vitamins, unless approved by investigator
• Use of medications/supplements for elevated lipids, blood pressure, or glucose
• Chronic use of non-steroidal anti-inflammatory or immunosuppressant medication
• Conditions requiring the use of steroids
• Unwillingness to refrain from blood donation prior to and during the study
• Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator
• Allergy or sensitivity to strawberries or any ingredient in the study powders