Back to resultsFast Food, Fatigue, and Inflammation (FOOD)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saturated Fat Meal
Oleic Sunflower Oil Meal
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring 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.
Sites / Locations
- Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1 (Saturated Fat Meal, Oleic Sunflower Oil Meal)
Arm 2 (Oleic Sunflower Oil Meal, Saturated Fat Meal)
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04247763
First Posted
January 28, 2020
Last Updated
August 31, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT04247763
Brief Title
Fast Food, Fatigue, and Inflammation
Acronym
FOOD
Official Title
Fast Food, Fatigue, and Inflammation: The FOOD Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2010 (Actual)
Primary Completion Date
June 11, 2013 (Actual)
Study Completion Date
June 11, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind: The data manager assigned arbitrary names to each meal so that only the data manager and the kitchen staff were unblinded.
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 (Saturated Fat Meal, Oleic Sunflower Oil Meal)
Arm Type
Experimental
Arm Title
Arm 2 (Oleic Sunflower Oil Meal, Saturated Fat Meal)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Saturated Fat Meal
Intervention Type
Other
Intervention Name(s)
Oleic Sunflower Oil Meal
Primary Outcome Measure Information:
Title
Post-Meal Change in C-reactive Protein
Description
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.
Time Frame
Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Title
Post-Meal Change in Serum Amyloid A
Description
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.
Time Frame
Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Title
Change in Intercellular adhesion molecule-1
Description
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.
Time Frame
Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Title
Change in Vascular cell adhesion molecule-1
Description
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.
Time Frame
Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Title
Fatigue at Follow-Up Visits
Description
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.
Time Frame
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.
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Kiecolt-Glaser
Organizational Affiliation
Ohio State Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32393980
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.
Results Reference
derived
Links:
URL
http://cancer.osu.edu
Description
Related Info
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Fast Food, Fatigue, and Inflammation
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