Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors
Condition: Cardiovascular Diseases; Osteoporosis; Breast Cancer; Endometrial Cancer
MeSH terms: Endometrial Neoplasms; Osteoporosis; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess whether alternative, high phytoestrogen dietary interventions result
      in favorable effects on biological parameters that have been associated with
      hormone-dependent cancers, cardiovascular disease, and osteoporosis.
    

Detailed description: 
      Broad health effects of endogenous and exogenous estrogens on diseases of aging, including
      hormone-dependent cancers, cardiovascular disease, and osteoporosis, are generally
      recognized. For example, estrogen replacement therapy (ERT) may increase the risk of
      subsequent breast and endometrial cancer, but also decreases the risk of coronary disease and
      fractures. Because of the increased cancer risk, many women seek out alternatives to ERT.
      Phytoestrogens, plant compounds that have estrogenic effects, have been a focus of interest
      as an alternative to ERT. The isoflavones and lignans are two major classes of phytoestrogens
      that occur in the food supply. Among the former, soy foods have attracted much interest,
      while among the latter, whole grains and seeds are sources in a typical diet. More
      specifically, women consuming a macrobiotic diet have been observed to have extremely high
      levels of phytoestrogen metabolites in their urine, perhaps 10 to 20 times that seen in women
      consuming an omnivorous diet. Proponents of a macrobiotic diet have proposed that it is
      beneficial in the context of cancer therapy, as well as for the prevention and treatment of
      cardiovascular disease.

      This study will investigate, in a randomized, three-arm study, the effects of two
      interventions that are high in phytoestrogens on various parameters related to estrogen
      metabolism and fibrinolysis. Approximately 120 women will be randomized to receive an
      American Heart Association (AHA) Step 1 diet, an AHA Step 2 diet + 10 g/day flax seed, or a
      macrobiotic dietary intervention. Blood and urine samples will be drawn at baseline, and at
      three, six, nine, and twelve months, to examine both short and long-term effects of these
      interventions. Outcomes include blood and urine levels of total estrogens and estradiol, and
      related metabolites; antigens to plasminogen activator inhibitor-1 (PAI-1) and tissue
      plasminogen activator (t-PA), fibrin D-dimer, and von Willebrand Factor; and endothelial
      function as measured by high-resolution ultrasound. Blood levels of antioxidant vitamins and
      retinoids will also be examined.

      This study should provide information on whether these alternative, high phytoestrogen
      dietary interventions result in favorable effects on these biological parameters that are
      related to risk of major diseases of aging.
    

Intervention name(s): American Heart Association Step 1 diet; American Heart Association Step 2 diet + 10 g/day flax seed; Macrobiotic dietary intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Primary purpose: Treatment
Keywords: Cardiovascular Diseases; Osteoporosis; Breast Cancer; Endometrial Cancer