Dietary Intervention in Persons With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Individuals diagnosed with metabolic syndrome are at a two-fold risk for developing
      cardiovascular disease. The investigators must identify strategies that can abort the
      development of cardiovascular disease. Inflammation and oxidative stress responsible for the
      pathogenesis of metabolic syndrome and CVD can be influenced by dietary changes. Strategic
      and novel interventions that include changing dietary patterns to include more antioxidant
      rich fruit and vegetables are pragmatic for primary prevention of CVD. Antioxidant rich
      fruits and vegetables, especially those with carotenoids (lycopene, lutein, zeaxanthin,
      alpha-carotene, and beta-carotene) have been efficacious in reducing the risk of CVD by
      decreasing inflammation and oxidative stress. The purpose of this study is to test the effect
      of a dietary antioxidant intervention on biomarkers of inflammation and oxidative stress in
      persons diagnosed with metabolic syndrome. The sample will be randomized into one of two
      groups. Group one (intervention) will drink an 11.5 ounce serving of V8 100% vegetable juice
      once per day for 30 days. The second group (control) will continue to consume their normal
      diet. We will measure biomarkers of inflammation (C-reactive protein) and oxidative stress
      (malondialdehyde) in the two groups at baseline and the end of the 30-day intervention.
    

Detailed description: 
      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.
    

Intervention name(s): Dietary Antioxidant (V8® Low Sodium 100% vegetable juice); Control group
Intervention type(s): Other; Other
Intervention description(s): Following completion of baseline data collection, participants will be randomized to one of two groups. Participants randomized to the intervention group will receive a month's supply of the V8® 100% Low-Sodium Vegetable juice as the dietary antioxidant intervention. Participants will be asked to drink one V8® juice each day for 30 days. Each V8® juice can is 11.5 ounces and can be consumed in divided amounts or all at once. The average daily intake of lycopene is estimated to be 5mg, one can of V8 juice provides 24 mg of lycopene. Thirty days duration for the intervention of V8® juice is based on previous data that indicates plasma antioxidant concentrations rise significantly within a two-week period and a plateau effect is reached within 4 weeks.; The control group will continue to be medically managed by their health care provider as usual. The control group will have the same visit and call schedule as the intervention group.
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The design is that of a two-group randomized controlled intervention study. Subjects (N=100) will be randomized to 1 of 2 groups (intervention group or usual care/control group). Subjects will be recruited from outpatient cardiology clinics. The intervention group will be given one 11.5 ounce can of V8® 100% vegetable juice to drink each day for 30 days in addition to their normal diet. The usual care group will continue to consume their normal diet. Data collection for both groups will occur at baseline, and at one-month post-baseline. Data will include sociodemographic and clinical information, 24-hr dietary recalls, carotenoid levels and biomarkers of inflammation and oxidative stress.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oxidative stress; metabolic syndrome; inflammation