Status:
COMPLETED
Effects of Alternative Healthy Eating Index-Based Diet on Inflammatory Markers and Breast Density in Healthy Participants
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
Breast Cancer Research Foundation
Conditions:
Healthy Subject
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
This trial studies the effects of a dietary intervention based on the Alternative Healthy Eating Index (AHEI) on inflammatory markers and breast density in healthy participants. The AHEI is a quantifi...
Detailed Description
OUTLINE: DIETARY INTERVENTION: Participants receive dietary counseling with a dietitian in person or via telephone to support adherence to a diet based on the AHEI guidelines once weekly for up to 12...
Eligibility Criteria
Inclusion
- Women will be eligible if they are nulliparous, aged 18-30, and score below 75 on the AHEI. Study eligibility will be assessed via online screening questionnaire and online Food Frequency Questionnaire (FFQ). These criteria were chosen because of our focus on the years before first birth as a critical period for establishing breast cancer risk
- Participants must be able to come to two clinic visits, complete questionnaires in English, and will be required to discontinue all vitamins and nutritional supplements during the study period
- DXA ONLY PILOT STUDY: Participants must be able to come to one visit in the Prevention Center where they will receive the consent form and undergo the DXA scan. No intervention will occur and there will be no follow-up assessments or measurements beyond the DXA scan
Exclusion
- Women will be ineligible if they are postmenopausal, pregnant, taking hormone therapy (e.g., oral contraceptives), or have chronic illnesses that are known to affect gastrointestinal absorption of nutrients
- Women who obtain a score of \>= 75 on the AHEI are also ineligible
- DXA ONLY PILOT STUDY: Women who are pregnant
Key Trial Info
Start Date :
October 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04062955
Start Date
October 28 2019
End Date
November 19 2020
Last Update
January 22 2021
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109