Clinical trial NCT04247763: Fast Food, Fatigue, and Inflammation
Official title: Fast Food, Fatigue, and Inflammation: The FOOD Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 58
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Post-Meal Change in C-reactive Protein
timeFrame: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
measure: Post-Meal Change in Serum Amyloid A
timeFrame: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
measure: Change in Intercellular adhesion molecule-1
timeFrame: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
measure: Change in Vascular cell adhesion molecule-1
timeFrame: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
measure: Fatigue at Follow-Up Visits
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State Comprehensive Cancer Center
name: Janice Kiecolt-Glaser
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madison AA, Belury MA, Andridge R, Shrout MR, Renna ME, Malarkey WB, Bailey MT, Kiecolt-Glaser JK. Afternoon distraction: a high-saturated-fat meal and endotoxemia impact postmeal attention in a randomized crossover trial. Am J Clin Nutr. 2020 Jun 1;111(6):1150-1158. doi: 10.1093/ajcn/nqaa085.