Brief Title
Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors
Official Title
Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors
Brief 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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Cardiovascular Diseases
Intervention
American Heart Association Step 1 diet
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Start Date
January 2001
Completion Date
December 2005
Eligibility Criteria
Inclusion Criteria:
THIS TRIAL IS RECRUITING IN THE NEW YORK METRO AREA ONLY
- Postmenopausal
- Weight within 90% to 120% of ideal body weight
Gender
Female
Ages
50 Years - 72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Dr. Lawrence Kushi, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00010829
Organization ID
P50AT000090-01P1
Secondary IDs
P50AT000090-01
Study Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Study Sponsor
Dr. Lawrence Kushi, Principal Investigator, Columbia University, Teachers College
Verification Date
August 2006