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

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ClinicalTrials.gov Identifier: NCT04062955
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : November 1, 2019
Sponsor:
Collaborators:
Breast Cancer Research Foundation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Subject Nulliparous Dietary Supplement: Dietary Intervention Procedure: Dual X-ray Absorptiometry Not Applicable

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adherence to the Alternative Healthy Eating Index and Effects on Inflammatory Markers and Breast Density
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : November 23, 2019
Estimated Study Completion Date : November 23, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Dietary Supplement: Dietary Intervention
Receive dietary counseling
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

Procedure: Dual X-ray Absorptiometry
Undergo DXA scan
Other Names:
  • 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


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of conducting a dietary intervention [ Time Frame: Up to 12 weeks ]
    Will be measured by adherence to Alternative Healthy Eating Index.


Secondary Outcome Measures :
  1. Change in inflammatory markers (IL-6, IL-1β, CRP, sTNFR-1, sTNFR-2, hsCRP) [ Time Frame: At baseline and week 12 ]
    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.

  2. Change in breast density [ Time Frame: At baseline and week 12 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PRIMARY DIETARY INTERVENTION STUDY: Nulliparous, aged 18-30, and score below 75 on the AHEI.
  • PRIMARY DIETARY INTERVENTION STUDY: Study eligibility will be assessed via self-administered questionnaire.
  • PRIMARY DIETARY INTERVENTION STUDY: 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.
  • PRIMARY DIETARY INTERVENTION STUDY: 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: Women will be eligible if they are ages 18-50. Study eligibility will be assessed via response to eligibility questions via email.
  • 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:

• Participants will be excluded if they do not meet the inclusion criteria

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062955


Contacts
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Contact: Holly Harris 206-667-2712 hharris@fredhutch.org

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Holly Harris    206-667-2712    hharris@fredhutch.org   
Principal Investigator: Holly Harris         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Breast Cancer Research Foundation
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Holly Harris Fred Hutch/University of Washington Cancer Consortium
More Information
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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT04062955     History of Changes
Other Study ID Numbers: RG1001812
NCI-2019-05132 ( Registry Identifier: NCI / CTRP )
8665 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No