NCT00010829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_2 cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2001

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

February 2, 2001

Last Update Submit

August 17, 2006

Conditions

Cardiovascular DiseasesOsteoporosisBreast CancerEndometrial Cancer

Keywords

Cardiovascular DiseasesOsteoporosisBreast CancerEndometrial Cancer

Interventions

American Heart Association Step 1 dietBEHAVIORAL
American Heart Association Step 2 diet + 10 g/day flax seedBEHAVIORAL
Macrobiotic dietary interventionBEHAVIORAL

Eligibility Criteria

Age50 Years - 72 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • THIS TRIAL IS RECRUITING IN THE NEW YORK METRO AREA ONLY
  • Postmenopausal
  • Weight within 90% to 120% of ideal body weight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesOsteoporosisBreast NeoplasmsEndometrial Neoplasms

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Dr. Lawrence Kushi

    Columbia University, Teachers College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 2, 2001

First Posted

February 5, 2001

Study Start

January 1, 2001

Study Completion

December 1, 2005

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(1)