Trial record 2 of 4 for:    Flaxseed | NCCAM

Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010829
First received: February 2, 2001
Last updated: August 17, 2006
Last verified: August 2006
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Osteoporosis
Breast Cancer
Endometrial Cancer
Behavioral: American Heart Association Step 1 diet
Behavioral: American Heart Association Step 2 diet + 10 g/day flax seed
Behavioral: Macrobiotic dietary intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Study Start Date: January 2001
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   50 Years to 72 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

THIS TRIAL IS RECRUITING IN THE NEW YORK METRO AREA ONLY

  • Postmenopausal
  • Weight within 90% to 120% of ideal body weight
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010829

Locations
United States, New York
Columbia University
New York, New York, United States
Sponsors and Collaborators
Investigators
Principal Investigator: Dr. Lawrence Kushi Columbia University, Teachers College
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00010829     History of Changes
Obsolete Identifiers: NCT00009425
Other Study ID Numbers: P50 AT000090-01P1, P50 AT000090-01
Study First Received: February 2, 2001
Last Updated: August 17, 2006
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Cardiovascular Diseases
Osteoporosis
Breast Cancer
Endometrial Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Cardiovascular Diseases
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Breast Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Estrogens
Phytoestrogens
Estrogens, Non-Steroidal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014