Clinical Trials Directory

Trials / Completed

CompletedNCT05826184

Time Restricted Eating With or Without a Fiber Supplement for Weight Management in Pediatric Cancer Survivors

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
13 (actual)
Sponsor
University of Illinois at Chicago · Academic / Other
Sex
All
Age
18 Years – 39 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTime restircted eating8 hour time restricted eating alone
BEHAVIORALTime restricted eating + prebiotic8 hour TRE with a prebiotic supplement

Timeline

Start date
2023-11-17
Primary completion
2025-07-01
Completion
2025-07-01
First posted
2023-04-24
Last updated
2025-10-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05826184. Inclusion in this directory is not an endorsement.