Effect of a Mediterranean Diet and Omega-3 Fatty Acids on Oxidative Stress and Endothelial Progenitor Cells (EPC's)
Condition: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      Problem of Interest:

      A typical American diet that is high in an intake of fats (especially saturated fats and
      cholesterol) is known to lead to high blood levels of cholesterol, hardening of the arteries,
      and increases the risk of heart disease. The American Heart Association recommendations to
      follow a diet that is low in the amount of fat, and specifically cholesterol, that is eaten
      can improve blood levels of cholesterol but can lead to a high intake of sugars (especially
      processed sugars) that can lead to obesity and continued heart problems.

      Studies of people who eat a diet that is typical of the Mediterranean region have shown that
      this type of diet leads to reductions in heart disease as well as forms of cancer. A typical
      Mediterranean diet has a large amount of fruit, vegetables, whole grain breads and cereals,
      beans, potatoes and seeds. Olive oil is the main source of fat and there is a daily use of
      dairy products (such as cheese and yogurt) in low to moderate amounts. The main meats are
      fish or poultry with rare red meat. Desserts are usually fruits with rare sweets. Wine is
      also used in low to moderate amounts with meals.

      No isolated aspect of the diet explains all of its benefits, but it is believed that the
      ingredient of the diet that most helps to reduce the risk of heart disease is the high amount
      of omega-3 fatty acids. Omega-3 fatty acids are found in fatty fish as well as in nuts and
      certain oils. Several studies of patients with either known heart disease or risk factors for
      heart disease have shown a reduction in heart disease events, such as heart attacks, as well
      as markers of heart disease risk when patients followed a Mediterranean diet. Other studies
      have shown that giving a supplement that contains omega-3 fatty acids to patients with heart
      disease or risk factors for heart disease also reduces heart disease events and markers of
      heart disease risk.

      In this current study we, the investigators at Emory University, plan to compare the effects
      of following a Mediterranean diet versus continuing to follow an American type diet and
      supplementing parts of the Mediterranean diet, including omega-3 fatty acids, on markers of
      heart disease risk. A third group will continue to follow their usual diet without
      supplements to serve as a control.

      How Problem Will be Studied:

      In this initial study we will compare three groups. One group will receive one month of
      prepared meals that will follow a Mediterranean diet. This group will also receive extensive
      counseling and education on how to maintain a Mediterranean diet. During the second month of
      the study this group will be encouraged to continue following a Mediterranean diet by
      themselves with assistance from a nutritionist. The second group will be asked to continue on
      their current diet and receive supplements that are important parts of the Mediterranean
      diet. These supplements will include an omega-3 fatty acid capsule, walnuts and grape juice.
      A third group will be asked to continue their current diet and level of activity without
      supplements to serve as a control. We will follow the effects on markers of heart disease
      risk. We will also determine if patients are able to continue following a Mediterranean diet
      on their own or whether simply taking supplements is easier.

      Advancement in Scientific Knowledge:

      This study will advance scientific knowledge by comparing the effects of following a
      Mediterranean diet versus simply taking supplements of the believed to be important aspects
      of the Mediterranean diet. We will also be able to determine if it is easier to follow a
      Mediterranean diet or take supplements for patients who are currently ingesting a typical
      American diet.

      Standard of Care:

      Currently the recommended diet for all Americans is a Step 1 American Heart Association diet
      that is low in fat and specifically low in saturated fats and cholesterol. As stated above,
      despite these recommendations, there is a growing problem of obesity in the United States and
      there is evidence to suggest that a Mediterranean diet may be better.
    


Intervention name(s): Mediterranean Diet; Mediterranean Dietary Supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The Mediterranean diet group will receive all meals as a prototypical Mediterranean diet for 4 consecutive weeks prepared by the GCRC metabolic kitchen with dietary instruction. During the second month of the study they will be asked to follow a Mediterranean diet using their own home-cooked meals; The subjects randomized to the typical diet + targeted Mediterranean dietary supplement group will not receive dietary counseling. They will be given a one-month supply of specific supplements by the GCRC nutritionists and advised to consume these daily, in addition to their usual diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Oxidative Stress; Diet, Mediterranean