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

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 Overview

• Status: Completed
• Conditions: Weight, Body
• Intervention / Treatment: Behavioral: Time restircted eating; Behavioral: Time restricted eating + prebiotic

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18-39 years old at time of consent
• Completed anti-tumor treatment for pediatric cancer
• BMI 25-39.99 kg/m2
• Able to provide (self or guardian) written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
• As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria:

Subjects meeting any of the criteria below may not participate in the study:

• Individuals <18 or >39 years of age
• Individuals on glucoregulatory medication
• Individuals with BMI ≥ 40kg/m2 and < 25kg/m2
• Individuals who are pregnant, trying to become pregnant or breast feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines at screening as well as prior to all DXA scans.
• Shift workers who maintain a work schedule that crosses 12:00 am > 1 day per week
• Individuals with a history of eating disorders
• Active infection requiring systemic therapy
• Uncontrolled HIV/AIDS or active viral hepatitis
• Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
• Other major comorbidity, as determined by study PI
• Illicit drug use (excluding self-reported marijuana) or excessive use of alcohol (i.e., > 2 drinks/day)
• Currently participating in Weight Watcher's or another weight loss program with a ≥ 3% weight loss in three months prior to recruitment
• History of: Myocardial infarction, Stroke, Congestive heart failure, Chronic hepatitis, Cirrhosis, Chronic pancreatitis
• History of solid organ transplantation
• Individual does not have access to the Internet
• Individuals who have taken antibiotics < 2 months prior to the initiation of the study
• Individuals who regularly use (≥ 3 times per week) prebiotics, probiotics, synbiotics, prebiotic supplements or laxatives within the past month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time restricted eating; Individuals will eat between 12-8pm ad libitum, fasting from 8-12pm.	Behavioral: Time restircted eating; 8 hour time restricted eating alone
Experimental: TRE+ prebiotic supplement; Individuals will eat between 12-8pm ad libitum, fasting from 8-12pn with the addition of a prebiotic fiber supplement with the first eating bout of the day.	Behavioral: Time restricted eating + prebiotic; 8 hour TRE with a prebiotic supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
acceptance of TRE in pediatric cancer survivors	TRE will be acceptable (≥ 16 on acceptability on Diet Satistfaction questionnaire).	12 weeks
Adherence to TRE	Adherence to TRE will be ≥ 80% throughout the intervention among participants randomized to this study arm	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	change from week 1-12
Body composition	fat free mass and fat mass via DXA	change from week 1-12
fasting Insulin	measured by enzymatic kit (uIU/ml)^4	change from week 1-12
fasting glucose	measured by enzymatic kit (mg/dl)	change from week 1-12
Blood pressure	systolic and diastolic blood pressure with cuff	change from week 1-12
Heart rate	Heart rate measured by blood pressure cuff	change from week 1-12
Gut microbial composition	16s RNA stool swab	Change from week 1-12
insulin resistance change	fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.	change from week 1-12
Hemoglobin A1c concentration	measured by enzymatic kit	change from week 1-12
Lipid concentration	measured by enzymatic kit	change from week 1-12
Glucagon like peptide 1 concentration	measured by enzymatic kit	change from week 1-12
peptide yy concentration	measured by enzymatic kit	change from week 1-12
circulating short chain fatty acid concentration	measured by enzymatic kit	change from week 1-12
c-reactive protein concentration	measured by enzymatic kit	change from week 1-12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
peripheral blood mononuclear cell (PBMC) telomerase activity	measured by enzymatic kit	change from week 1-12

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Kelsey Gabel, PhD, UIC

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Body Weight; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Dietary Fiber; Polysaccharides, Bacterial; Prebiotics
• Other Study ID Numbers: STUDY2022-0745

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No