Influence of Freeze Dried Strawberry Consumption on Gut Microbiota and Cardiovascular Health.

A randomized, double-blind, controlled crossover design will compare the short-term (two and
four week) response to FDSP intake compared to an isocaloric control powder in overweight and
obese adults. Twenty overweight or obese male or postmenopausal females (40-65 years of age)
will be randomized to consume 39 g of FDSP or a control powder for four weeks in a crossover
design with a four week washout period. Changes in stool microbial communities and microbial
metabolites will be assessed, and examined for their potential influence on microvascular
function.

Inclusion Criteria:

- Male or postmenopausal female: 40-65 years

- Women: lack of menses for at least two years.

- Subject is willing and able to comply with the study protocols.

- Subject is willing to participate in all study procedures

- BMI 25.0 - 35 kg/m2

Exclusion Criteria:

- BMI ≥ 35 kg/m2

- Dislike or allergy for strawberries or strawberry products

- Self-reported use of daily anticoagulation agents including aspirin, NSAIDs

- Vegan, Vegetarians, food faddists or those consuming a non-traditional diet

- Fruit consumption ≥ 2 cups/day

- Regular consumption of strawberries (2-3 cups/week)

- Vegetable consumption ≥ 3 cups/day for females

- Fatty Fish ≥ 3 times/week

- Coffee/tea ≥ 3 cups/day

- Dark chocolate ≥ 3 oz/day

- Self-reported restriction of physical activity due to a chronic health condition

- Self-reported chronic/routine high intensity exercise

- Self-reported diabetes

- Blood pressure ≥ 140/90 mm Hg

- Self-reported renal or liver disease

- Self-reported heart disease, which includes cardiovascular events and stroke

- Inability to properly place or wear the PAT probes or abnormal measurements on pre-
screening PAT

- Abnormal Metabolic or CBC panels (laboratory values outside the reference range) if
determined to be clinically significant by the study physician.

- Self-reported cancer within past 5 years

- Self-reported malabsorption

- Currently taking prescription drugs or supplements.

- Use of multi-vitamin and mineral other than a general formula of vitamins and minerals
that meet the RDA

- Not willing to stop any supplement use, including herbal, plant or botanical, fish
oil, oil supplements a month prior to study enrollment.

- Indications of substance or alcohol abuse within the last 3 years

- Screening LDL ≥ 190 mg/dl for those who have 0-1 major risk factors apart from LDL
cholesterol (i.e. family history of premature coronary artery disease (male first
degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette
smoker, HDL-C ≤ 40 mg/dL].

- Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL
cholesterol [i.e. family history of premature coronary artery disease (male first
degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette
smoker, HDL-C ≤ 40 mg/dL]. (using NCEP calculator
http://cvdrisk.nhlbi.nih.gov/calculator.asp);

- Screening LDL ≥ 130 mg/dl for those who have 2 major risk factors apart from LDL
cholesterol [i.e. family history of premature coronary artery disease (male first
degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette
smoker, HDL-C ≤ 40 mg/dL], and a Framingham 10-year Risk Score 10-20% (using NCEP
calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp).

- Current enrollee in a clinical research study.