Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
NCT Number: NCT04062955
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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Notify Me18 year–50 year
Female
Interventional
Not applicable
Seattle, Washington, 98109, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive dietary counseling
Other names: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
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
Ancillary studies
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.
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.
Fred Hutchinson Cancer Center
Other
Adherence to the Alternative Healthy Eating Index and Effects on Inflammatory Markers and Breast Density
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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