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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04062955
Other study ID # RG1001812
Secondary ID NCI-2019-0513286
Status Completed
Phase N/A
First received
Last updated
Start date October 28, 2019
Est. completion date November 19, 2020

Study information

Verified date January 2021
Source Fred Hutchinson Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 quantifiable measure of diet quality designed to target food and macronutrient sources that are associated with chronic disease risk. Adherence to the AHEI may be associated with a reduction in inflammatory biomarkers and sex steroid hormone levels compared to other dietary patterns/scores.


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 weeks. DUAL X-RAY ABSORPTIOMETRY (DXA) ONLY STUDY: Participants undergo DXA scan for breast density measurement at baseline and at 12 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date November 19, 2020
Est. primary completion date November 19, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Dietary Intervention
Receive dietary counseling
Procedure:
Dual X-ray Absorptiometry
Undergo DXA scan
Other:
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Research Center Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in inflammatory markers (IL-6, IL-1ß, CRP, sTNFR-1, sTNFR-2, hsCRP) Levels of IL-6, IL-1ß, sTNFR-1, and sTNFR-2 will be measured by immunoassay. hsCRP levels will be measured using a high-sensitivity latex-enhanced immunonephelometric assay on a BNII analyzer. At baseline and week 12
Primary Change in breast density Breast density will be measured by dual x-ray absorptiometry. Depending on the distribution of the data a paired t-test or Wilcoxon signed-rank test will be used. At baseline and week 12
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