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

NCT04062955 | Completed

• 3 other identifiers: RG1001812NCI-2019-051328665
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subject

Keywords

Breast - Female

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Prevention (dietary intervention)

EXPERIMENTAL

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; Procedure: Dual X-ray Absorptiometry; Other: Questionnaire Administration

Interventions

Dietary Intervention DIETARY_SUPPLEMENT

Receive dietary counseling

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Prevention (dietary intervention)

Dual X-ray Absorptiometry PROCEDURE

Undergo DXA scan

Also known as: 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

Prevention (dietary intervention)

Questionnaire Administration OTHER

Ancillary studies

Prevention (dietary intervention)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Diet Therapy; Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Holly Harris

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 20, 2019
• Study Start: October 28, 2019
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)