Dietary Intervention in Persons With Metabolic Syndrome

SPECIFIC AIMS An estimated 47 million Americans have been diagnosed with metabolic syndrome.
Glucose intolerance, abdominal obesity, hypertension and abnormal lipid profile are the
identified traits of metabolic syndrome. Metabolic syndrome is a grouping of conditions that
collectively are associated with a two-fold risk of cardiovascular disease (CVD).
Inflammation and oxidative stress are contributing factors for the development of
atherosclerotic plaque in CVD and are the initial pathological responses for each of the
abnormal conditions associated with metabolic syndrome. Consequently, reducing inflammation
and oxidative stress are considered appropriate targets for interventions designed for
primary prevention of CVD and metabolic syndrome. Primary prevention is the fundamental
strategy to reduce cardiovascular mortality. Given the high mortality rate associated with
CVD and its vast impact on healthcare expenditures, it is imperative that the investigators
develop novel interventions for primary prevention of CVD in persons with metabolic syndrome.

Interventions designed to address primary prevention are considered to be the most effective
and logical strategy to improve health before the devastating burden of CVD becomes evident.
There is an arsenal of CVD treatment modalities available today with many pharmacologic
interventions, however, these come at an enormous cost to individuals and to our healthcare
system. To address a gap in the treatment of CVD, nonpharmacologic interventions provide an
alternative strategy without expense or undesirable adverse side effects. Simple, inexpensive
dietary interventions can have a significant impact on an individual's health and are often
overlooked by mainstream healthcare providers because of their simplicity. The impact of
increasing fruit and vegetables, which are loaded with antioxidants, into a dietary pattern
has consistently been supported in research and is recommended in all primary prevention
guidelines. Yet, nine out of ten Americans get less than the recommended amounts of fruits
and vegetables in their diet.

The purpose of this study is to test the effect of a dietary antioxidant intervention on
inflammation and oxidative stress in individuals with metabolic syndrome. The study has the
potential to reduce the incidence of cardiovascular disease. This proposal will address a
major goal of Healthy People 2020: Improving cardiovascular health through prevention,
detection, and treatment, specifically addressing primary prevention of CVD in individuals
with metabolic syndrome.

Specific Aim #1: To test the effect of a dietary antioxidant intervention on biomarkers of
inflammation and oxidative stress in individuals who have metabolic syndrome.

Hypothesis #1: Compared to a usual care control group and to their own baseline, individuals
randomized to a dietary antioxidant intervention (30-day intake of V8® 100% Low-Sodium
Vegetable juice) group will have lower levels of C-reactive protein (CRP) and malondialdehyde
(MDA) at one month from baseline. CRP is a biomarker of inflammation and is an independent
predictor of cardiovascular disease. MDA is the most prevalent byproduct of lipid
peroxidation during oxidative stress and is considered an excellent measurement for use in
clinical trials to evaluate oxidative stress.

Inclusion Criteria: Subjects will be individuals who have a diagnosis of metabolic syndrome
without overt CVD as defined by the National Cholesterol Education Program (NCEP) as
evidenced by having at least 3 of the 5 following conditions:

1. Hypertension defined as SBP >130mmHg and diastolic >85mmHg

2. Abdominal obesity with a waist circumference greater than 88cm in women and greater
than 102 cm in men

3. Triglycerides level greater than 150mg/dL

4. HDL levels less than 50mg/dL in women and less than 40mg/dL in men

5. Fasting glucose level greater than 100mg/dL Additional inclusion criteria include the
ability to read and speak English, and have no cognitive impairment that precludes
giving informed consent or ability to follow protocol instructions.

Exclusion Criteria: Subjects will be excluded from the study if they: a) are less than
21 years of age; b) have a terminal illness; c) have impaired cognition; d) have a
strong dislike, or have a potential food-drug interaction to V8® Low Sodium 100%
vegetable juice; or e) co-existing illness documented in the medical record or
self-reported associated with systemic inflammation (e.g. rheumatoid arthritis, acute
systemic infection).