This double-blind, randomized crossover trial assessed inflammation and fatigue following a fast-food-type meal (saturated fat) compared to a healthier meal (monounsaturated fat) in breast cancer survivors and benign controls (women who had an initial abnormal test for breast cancer).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
58
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Post-Meal Change in C-reactive Protein
Serum CRP was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It was measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions.
Time frame: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Post-Meal Change in Serum Amyloid A
Serum Amyloid A was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It as measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions.
Time frame: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Change in Intercellular adhesion molecule-1
sICAM-1 was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It was measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions.
Time frame: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Change in Vascular cell adhesion molecule-1
sVCAM-1 was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It was measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions.
Time frame: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Fatigue at Follow-Up Visits
The 30-item Multidimensional Fatigue Symptom Inventory-Short form assesses behavioral, cognitive, physical, and affective expressions of fatigue. It provides a very good measure of the multidimensional aspects of fatigue, allows for comparisons between fatigued and non-fatigued individuals, and has subscales measuring general, physical, emotional, mental, and vigor aspects of fatigue, as well as a total score.
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Time frame: The survey was administered upon admission to the Clinical Research Center before the meal at both visits and at 18- and 30-month follow-up visits.