Fast Food, Fatigue, and Inflammation (FOOD)

The Ohio State University

Status

Completed

Conditions

Breast Cancer

Treatments

Other: Saturated Fat Meal

Other: Oleic Sunflower Oil Meal

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04247763

NCI-2014-01312 (Registry Identifier)

OSU-10078

Details and patient eligibility

About

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).

Enrollment

58 patients

Sex

Female

Volunteers

No Healthy Volunteers

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.