Cardiovascular DiseasesPhase 2NCT00010829
Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors
A Phase 2 study testing American Heart Association Step 1 diet, American Heart Association Step 2 diet + 10 g/day flax seed and Macrobiotic dietary intervention in people with Cardiovascular Diseases and Osteoporosis, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 72 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Osteoporosis, Breast Cancer
- What is being tested?
- American Heart Association Step 1 diet, American Heart Association Step 2 diet + 10 g/day flax seed and Macrobiotic dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Dec 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 72 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- THIS TRIAL IS RECRUITING IN THE NEW YORK METRO AREA ONLY
- Postmenopausal
- Weight within 90% to 120% of ideal body weight
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- American Heart Association Step 1 diet, American Heart Association Step 2 diet + 10 g/day flax seed, Macrobiotic dietary intervention
- Keywords
- Cardiovascular Diseases, Osteoporosis, Breast Cancer, Endometrial Cancer
- Medical subject headings
- Cardiovascular Diseases, Osteoporosis, Breast Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
American Heart Association Step 1 dietBehavioural
American Heart Association Step 2 diet + 10 g/day flax seedBehavioural
Macrobiotic dietary interventionBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2001 (estimated)
- Study startJan 2001
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Dr. Lawrence Kushi, Principal investigator, Columbia University, Teachers College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010829
- Sponsor's protocol ID
- P50AT000090-01P1
- Other IDs
- P50AT000090-01
- Status last verified
- Aug 2006
- First submitted
- 2 Feb 2001
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors
- ClinicalTrials.gov ID
- NCT00010829
- Acronym / sponsor ID
- P50AT000090-01P1
- Keywords
- Cardiovascular Diseases, Osteoporosis, Breast Cancer, Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Jan 2001
- Study completion
- Dec 2005
- First posted
- 5 Feb 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 50 to 72 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- THIS TRIAL IS RECRUITING IN THE NEW YORK METRO AREA ONLY
- Postmenopausal
- Weight within 90% to 120% of ideal body weight
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| American Heart Association Step 1 diet | Behavioural | – |
| American Heart Association Step 2 diet + 10 g/day flax seed | Behavioural | – |
| Macrobiotic dietary intervention | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Lawrence Kushi principal investigator
Columbia University, Teachers College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing American Heart Association Step 1 diet, American Heart Association Step 2 diet + 10 g/day flax seed and Macrobiotic dietary intervention in people with Cardiovascular Diseases and Osteoporosis, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006; AzTrials last refreshed its copy on 6 Nov 2026.