Beef in an Optimal Lean Diet (BOLD) Effects on Metabolic Syndrome
Condition: Metabolic Syndrome; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The proposed research will provide important information about the role of 2 intervention
      diets that provide different amounts of lean beef and meet current nutrient recommendations
      for the treatment of Metabolic Syndrome (MetSyn), a chronic disease that is still increasing
      in prevalence at alarming rates. The experimental and diet designs will enable us to evaluate
      lifestyle interventions for MetSyn for persons who maintain weight, lose weight and maintain
      their weight loss, as is currently recommended in clinical practice. Importantly, the
      investigators will compare a diet high in lean beef (5 oz/day) which is compositionally
      similar (i.e., energy and nutrients) to the modified-DASH diet, a low beef diet which has
      become the Gold Standard for the management of cardiovascular disease (CVD) risk factors,
      including MetSyn. In addition, the investigators also will evaluate a moderate-high protein
      diet (BOLD+) that is higher in total protein (from mixed sources including lean beef,
      7oz/day) than the BOLD diet, on CVD risk factors in persons with MetSyn. A follow-up study
      was conducted to assess dietary compliance in a sub-sample of the population at 12-months;
      participants were not informed of this end-point and additional consent was obtained.

      Hypotheses:

        1. Healthful isocaloric diets that include lean beef as the primary source of protein (BOLD
           diet) with average (18%; BOLD) or moderate-high (28%; BOLD+) total protein intake will
           show similar or greater reductions in CVD risk, respectively when compared to a
           modified-DASH diet.

        2. A healthful weight-loss diet, including lean beef as the primary source of protein in a
           high-moderate protein diet (BOLD+ diet), plus regular exercise (BOLD+ + ex) will reduce
           body weight equal to that of a BOLD + ex and DASH + ex intervention, but may improve CV
           risk factors (such as BP and TG), and therefore reduce the prevalence of MetSyn more
           than a BOLD + ex and DASH + ex intervention.

        3. The BOLD diet will be more effective than the modified-DASH diet, and the BOLD+ diet
           more effective than the BOLD diet in maintaining the CVD benefits attained during phases
           1 and 2. Dietary adherence will be better on the BOLD and BOLD + diets compared with the
           modified DASH diet.
    


Intervention name(s): BOLD Diet; BOLD-X Diet; Modified DASH Diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Low-fat, high fruit and vegetable diet that includes lean beef (5oz/day); Low-fat, moderate-high protein diet (BOLD+) that is higher in total protein (from mixed sources including lean beef, 7oz/day) than the BOLD diet. Also high in fruits and vegetables; Low-fat, high fruit and vegetable diet which has become the Gold Standard for the management of cardiovascular disease (CVD) risk factors and metabolic syndrome
Other intervention name(s): Low fat, Step II diet; Low fat, moderate protein; DASH diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic syndrome; Lean Beef; CVD