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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 : December 6, 2019
Sponsor:
Collaborators:
Breast Cancer Research Foundation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE August 13, 2019
First Posted Date  ICMJE August 20, 2019
Last Update Posted Date December 6, 2019
Actual Study Start Date  ICMJE October 28, 2019
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
Feasibility of conducting a dietary intervention [ Time Frame: Up to 12 weeks ]
Will be measured by adherence to Alternative Healthy Eating Index.
Change History Complete list of historical versions of study NCT04062955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Alternative Healthy Eating Index-Based Diet on Inflammatory Markers and Breast Density in Healthy Participants
Official Title  ICMJE Adherence to the Alternative Healthy Eating Index and Effects on Inflammatory Markers and Breast Density
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthy Subject
Intervention  ICMJE
  • 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
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE 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.

Interventions:
  • Dietary Supplement: Dietary Intervention
  • Procedure: Dual X-ray Absorptiometry
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2019)
26
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2019)
23
Estimated Study Completion Date  ICMJE May 15, 2020
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Holly Harris 206-667-2712 hharris@fredhutch.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04062955
Other Study ID Numbers  ICMJE RG1001812
NCI-2019-05132 ( Registry Identifier: NCI / CTRP )
8665 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE
  • Breast Cancer Research Foundation
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Holly Harris Fred Hutch/University of Washington Cancer Consortium
PRS Account Fred Hutchinson Cancer Research Center
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP