Fast Food, Fatigue, and Inflammation

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Saturated Fat Meal; Other: Oleic Sunflower Oil Meal

• Registration Number: NCT04247763
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-13
• Primary Completion: 2013-06-11
• Study Completion: 2013-06-11
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1 (Saturated Fat Meal, Oleic Sunflower Oil Meal)	Saturated Fat Meal	-
Arm 2 (Oleic Sunflower Oil Meal, Saturated Fat Meal)	Oleic Sunflower Oil Meal	-
Arm 1 (Saturated Fat Meal, Oleic Sunflower Oil Meal)	Oleic Sunflower Oil Meal	-
Arm 2 (Oleic Sunflower Oil Meal, Saturated Fat Meal)	Saturated Fat Meal	-

Primary Outcome Measures

Name	Time	Method
Post-Meal Change in C-reactive Protein	Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal	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.
Fatigue at Follow-Up Visits	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.	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.
Change in Vascular cell adhesion molecule-1	Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal	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.
Post-Meal Change in Serum Amyloid A	Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal	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.
Change in Intercellular adhesion molecule-1	Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal	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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States