Fast Food, Fatigue, and Inflammation

Breast Cancer Clinical Trial

— FOOD  

Official title:

Fast Food, Fatigue, and Inflammation: The FOOD Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04247763
• Other study ID #: OSU-10078
• Secondary ID: NCI-2014-01312
• Status: Completed
• Phase: N/A
• Start date: December 13, 2010
• Est. completion date: June 11, 2013

Study information

• Verified date: August 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 11, 2013
• Est. primary completion date: June 11, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Inflammation

Intervention

Other:
• Saturated Fat Meal

• Oleic Sunflower Oil Meal

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.

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