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

NCT ID: NCT00010829

Last Updated: 2006-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases Osteoporosis Breast Cancer Endometrial Cancer

Keywords

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Cardiovascular Diseases Osteoporosis Breast Cancer Endometrial Cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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American Heart Association Step 1 diet

Intervention Type BEHAVIORAL

American Heart Association Step 2 diet + 10 g/day flax seed

Intervention Type BEHAVIORAL

Macrobiotic dietary intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

THIS TRIAL IS RECRUITING IN THE NEW YORK METRO AREA ONLY

* Postmenopausal
* Weight within 90% to 120% of ideal body weight
Minimum Eligible Age

50 Years

Maximum Eligible Age

72 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Dr. Lawrence Kushi

Role: PRINCIPAL_INVESTIGATOR

Columbia University, Teachers College

Locations

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Columbia University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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P50AT000090-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P50AT000090-01P1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT00009425

Identifier Type: -

Identifier Source: nct_alias