Effects of Alternative Healthy Eating Index-Based Diet on Inflammatory Markers and Breast Density in Healthy Participants

Study Overview
=================
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 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.

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

Official Title
-----------------
Adherence to the Alternative Healthy Eating Index and Effects on Inflammatory Markers and Breast Density

Conditions
-----------------
Healthy Subject

Intervention / Treatment
-----------------
* Dietary Supplement: Dietary Intervention
* Procedure: Dual X-ray Absorptiometry
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention (dietary intervention)<br>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. DXA ONLY STUDY: Participants undergo DXA scan for breast density measurement at baseline and at 12 weeks. | Dietary Supplement: Dietary Intervention<br>* Receive dietary counseling<br>* Other names: Nutritional Interventions;Procedure: Dual X-ray Absorptiometry<br>* Undergo DXA scan<br>* Other names: DXA SCAN;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammatory markers (IL-6, IL-1β, CRP, sTNFR-1, sTNFR-2, hsCRP) | Levels of IL-6, IL-1β, 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast - Female