This study aims to address a critical gap in pediatric oncology survivorship care by exploring innovative solutions to addressing obesity and its comorbidities in pediatric cancer survivors. The majority (99%) of pediatric cancer survivors will develop severe chronic health conditions by age 50, with 96% developing at least one severe/disabling, life threating or fatal chronic health condition. Obesity, cardiovascular, and metabolic diseases are the most common treatment-related late effects among pediatric cancer survivors. Improving diet and reducing obesity has the potential to dramatically improve the quality of life and long-term health of pediatric cancer survivors. Utilization of a prebiotic fiber supplement along with TRE amy improve the gut microbiome, short-chain fatty acid synthesis, and hunger hormones to further improve weight loss with TRE and a greater decrease in cardiometabolic risk. The aims of this study are to test the safety, feasibility, and acceptability of 8-h TRE or 8-h TRE with a fiber supplement among young adult (YA) pediatric cancer survivors. The investigators further strive to examine the preliminary efficacy of TRE on body weight, body composition, glucose regulation, and cardiovascular risk markers. Data obtained will be used to inform a larger efficacy trial of TRE among adolescent and young adult pediatric cancer survivors. Given that a majority of pediatric cancer survivors will develop severe chronic health conditions by age 50, with 96% developing at least one severe/disabling, life threating or fatal chronic health condition exploring accessible nutritional strategies to improve long term health trajectory of 70,000+ AYA diagnosed with cancer each year in the United States. This study of TRE will provide important preliminary evidence of the benefits of this nutrition therapy for YA pediatric cancer survivors. The long-term goal of this line of inquiry is to improve both short and long-term outcomes for YA pediatric cancer survivors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
8 hour time restricted eating alone
8 hour TRE with a prebiotic supplement
University of Illinois at Chicago
Chicago, Illinois, United States
feasibility of TRE in pediatric cancer survivors
Clinicians will refer ≥ 75% of AYA pediatric cancer survivors that are eligible, we will screen and enroll ≥ 50% of those referred, participants will complete ≥ 80% of planned study visits, and we will retain ≥ 80% of participants in both study arms through the end of the intervention.
Time frame: 1 year
acceptance of TRE in pediatric cancer survivors
TRE will be acceptable (≥ 16 on acceptability on Diet Satistfaction questionnaire).
Time frame: 12 weeks
Adherence to TRE
Adherence to TRE will be ≥ 80% throughout the intervention among participants randomized to this study arm
Time frame: 12 weeks
body weight (kg)
Body weight assessed to the nearest 0.25 kg every week without shoes and in light clothing using a balance beam scale (HealthOMeter, Boca Raton, FL).
Time frame: change from week 1-12
Body composition
fat free mass and fat mass via DXA
Time frame: change from week 1-12
fasting Insulin
measured by enzymatic kit (uIU/ml)\^4
Time frame: change from week 1-12
fasting glucose
measured by enzymatic kit (mg/dl)
Time frame: change from week 1-12
insulin resistance change
fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
Time frame: change from week 1-12
Hemoglobin A1c concentration
measured by enzymatic kit
Time frame: change from week 1-12
Blood pressure
systolic and diastolic blood pressure with cuff
Time frame: change from week 1-12
Heart rate
Heart rate measured by blood pressure cuff
Time frame: change from week 1-12
Lipid concentration
measured by enzymatic kit
Time frame: change from week 1-12
Gut microbial composition
16s RNA stool swab
Time frame: Change from week 1-12
Glucagon like peptide 1 concentration
measured by enzymatic kit
Time frame: change from week 1-12
peptide yy concentration
measured by enzymatic kit
Time frame: change from week 1-12
circulating short chain fatty acid concentration
measured by enzymatic kit
Time frame: change from week 1-12
c-reactive protein concentration
measured by enzymatic kit
Time frame: change from week 1-12
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