Fast Food, Fatigue, and Inflammation

Fast Food, Fatigue, and Inflammation: The FOOD Study

Sponsors

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Collaborator: National Cancer Institute (NCI)

Source 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).

Overall Status Completed
Start Date 2010-12-13
Completion Date 2013-06-11
Primary Completion Date 2013-06-11
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
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
Change in Intercellular adhesion molecule-1 Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
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
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.
Enrollment 58
Condition
Intervention

Intervention Type: Other

Intervention Name: Saturated Fat Meal

Intervention Type: Other

Intervention Name: Oleic Sunflower Oil Meal

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.

Gender:

Female

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Janice Kiecolt-Glaser Principal Investigator Ohio State Comprehensive Cancer Center
Location
Facility: Ohio State University Comprehensive Cancer Center
Location Countries

United States

Verification Date

2020-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Ohio State University Comprehensive Cancer Center

Investigator Full Name: Janice Kiecolt-Glaser

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm 1 (Saturated Fat Meal, Oleic Sunflower Oil Meal)

Type: Experimental

Label: Arm 2 (Oleic Sunflower Oil Meal, Saturated Fat Meal)

Type: Active Comparator

Acronym FOOD
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

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

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

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