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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-28

Study Completion Date

2020-11-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Subject

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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Prevention (dietary intervention)

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.

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type DIETARY_SUPPLEMENT

Receive dietary counseling

Dual X-ray Absorptiometry

Intervention Type PROCEDURE

Undergo DXA scan

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Dietary Intervention

Receive dietary counseling

Intervention Type DIETARY_SUPPLEMENT

Dual X-ray Absorptiometry

Undergo DXA scan

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Dietary Modification intervention, dietary Nutrition Intervention Nutrition Interventions Nutritional Interventions BMD scan bone mineral density scan DEXA DEXA Scan dual energy x-ray absorptiometric scan Dual Energy X-ray Absorptiometry Dual X-Ray Absorptometry DXA DXA SCAN

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes