Fast Food, Fatigue, and Inflammation

Study Overview
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Brief Summary
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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).

Official Title
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Fast Food, Fatigue, and Inflammation: The FOOD Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Saturated Fat Meal
* Other: Oleic Sunflower Oil Meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: We recruited a subset of a larger parent longitudinal observational study to participate in this study. Initially, participants were recruited following an abnormal mammogram, which resulted in either a malignant (cancer group) or benign (non-cancer control group) diagnosis. Exclusion Criteria: A history of any prior cancer except basal or squamous cell, chronic obstructive pulmonary disease, evidence of liver or kidney failure, symptomatic ischemic heart disease, significant visual or auditory problems, cognitive impairment, major medical conditions involving the immune system such as diabetes, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, alcohol or drug abuse, marked and recurrent gastrointestinal problems, or regular use of medications with major immunological consequences, e.g., steroids.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized crossover trial: participants were randomized to sequence of meal type; they ate one high saturated fat meal and one high oleic sunflower oil meal with 1-4 weeks washout in between meals
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 (Saturated Fat Meal, Oleic Sunflower Oil Meal)<br> | Other: Saturated Fat Meal<br> <br> Other: Oleic Sunflower Oil Meal<br> <br> |
| Active Comparator: Arm 2 (Oleic Sunflower Oil Meal, Saturated Fat Meal)<br> | Other: Saturated Fat Meal<br> <br> Other: Oleic Sunflower Oil Meal<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer