Fast Food, Fatigue, and Inflammation

NCT04247763 | Completed DMC

• 2 other identifiers: OSU-10078NCI-2014-01312
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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.

Study Arms (2)

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

EXPERIMENTAL

Other: Saturated Fat Meal; Other: Oleic Sunflower Oil Meal

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

ACTIVE COMPARATOR

Other: Saturated Fat Meal; Other: Oleic Sunflower Oil Meal

Interventions

Saturated Fat Meal OTHER

Arm 1 (Saturated Fat Meal, Oleic Sunflower Oil Meal); Arm 2 (Oleic Sunflower Oil Meal, Saturated Fat Meal)

Oleic Sunflower Oil Meal OTHER

Arm 1 (Saturated Fat Meal, Oleic Sunflower Oil Meal); Arm 2 (Oleic Sunflower Oil Meal, Saturated Fat Meal)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 32393980 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janice Kiecolt-Glaser

  Ohio State Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind: The data manager assigned arbitrary names to each meal so that only the data manager and the kitchen staff were unblinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: December 13, 2010
• Primary Completion: June 11, 2013
• Study Completion: June 11, 2013
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)