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

NCT05826184 | Completed

• 1 other identifier: STUDY2022-0745
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Weight, Body

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• body weight (kg)

  change from week 1-12

• Body composition

  change from week 1-12

• fasting Insulin

  change from week 1-12

• fasting glucose

  change from week 1-12

• insulin resistance change

  change from week 1-12

Other Outcomes (1)

• peripheral blood mononuclear cell (PBMC) telomerase activity

  change from week 1-12

Study Arms (2)

Time restricted eating

EXPERIMENTAL

Individuals will eat between 12-8pm ad libitum, fasting from 8-12pm.

Behavioral: Time restircted eating

TRE+ prebiotic supplement

EXPERIMENTAL

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

Interventions

Time restircted eating BEHAVIORAL

8 hour time restricted eating alone

Time restricted eating

Time restricted eating + prebiotic BEHAVIORAL

8 hour TRE with a prebiotic supplement

TRE+ prebiotic supplement

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Body Weight

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Kelsey Gabel, PhD

  UIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinial Assistant Professor and Postdoctoral Researcher

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 24, 2023
• Study Start: November 17, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)