Effect of a Low Glycemic Index Diet on Breast Density

NCT ID: NCT01237938

Last Updated: 2014-04-03

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

TERMINATED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Brief Summary

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This study is a Pilot Phase II cancer intervention trial of a low glycemic index diet to reduce mammographic density in women at high risk for breast cancer.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Low Glycemic Diet

Group Type EXPERIMENTAL

Low Glycemic Diet

Intervention Type BEHAVIORAL

Changing to low glycemic diet

Interventions

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Low Glycemic Diet

Changing to low glycemic diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Are between 40 and 60 years of age
* Still menstruating with at least 10 menstrual cycles in the previous 12 months
* Not Taking hormone replacement therapy
* Stable oral contraceptive use (no changes is use in past 12 months nor changes intended during interventional period)
* Have not been previously diagnosed with breast cancer, DCIS,lobular carcinoma in situ, atypical lobular hyperplasia or atypical hyperplasia
* No history of breast augmentation or reduction surgery
* Have no history of any other malignancy (excluding non-melanoma skin cancer) in the previous 5 years
* Have no history of diabetes or other metabolic diseases requiring dietary modification
* Have a study baseline mammographic density of at least 50% as estimated by mammographer
* BIRADS 1 or 2 mammogram if first ever mammogram, otherwise stable mammogram (no change since previous year)
* Have not followed a weight reduction or Atkins typs diet in the past 6 months Not pregnant or lactating in the past 12 months, nor intending pregnancy during the study period
* Successful completion of three baseline telephone-administered 24- hour dietary recalls
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan McCann, PhD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

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Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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I 71005

Identifier Type: -

Identifier Source: org_study_id

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