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OpenTrials
Completed

NCT Number: NCT05826184

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.

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Key information

Conditions

Weight, Body Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time restircted eating

Behavioral

8 hour time restricted eating alone

Time restricted eating + prebiotic

Behavioral

8 hour TRE with a prebiotic supplement

Primary outcomes

  1. feasibility of TRE in pediatric cancer survivors

    Time frame: 1 year

    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.

  2. acceptance of TRE in pediatric cancer survivors

    Time frame: 12 weeks

    TRE will be acceptable (≥ 16 on acceptability on Diet Satistfaction questionnaire).

  3. Adherence to TRE

    Time frame: 12 weeks

    Adherence to TRE will be ≥ 80% throughout the intervention among participants randomized to this study arm

Secondary outcomes

  1. body weight (kg)

    Time frame: change from week 1-12

    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).

  2. Body composition

    Time frame: change from week 1-12

    fat free mass and fat mass via DXA

  3. fasting Insulin

    Time frame: change from week 1-12

    measured by enzymatic kit (uIU/ml)^4

  4. fasting glucose

    Time frame: change from week 1-12

    measured by enzymatic kit (mg/dl)

  5. insulin resistance change

    Time frame: change from week 1-12

    fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.

  6. Hemoglobin A1c concentration

    Time frame: change from week 1-12

    measured by enzymatic kit

  7. Blood pressure

    Time frame: change from week 1-12

    systolic and diastolic blood pressure with cuff

  8. Heart rate

    Time frame: change from week 1-12

    Heart rate measured by blood pressure cuff

  9. Lipid concentration

    Time frame: change from week 1-12

    measured by enzymatic kit

  10. Gut microbial composition

    Time frame: Change from week 1-12

    16s RNA stool swab

  11. Glucagon like peptide 1 concentration

    Time frame: change from week 1-12

    measured by enzymatic kit

  12. peptide yy concentration

    Time frame: change from week 1-12

    measured by enzymatic kit

  13. circulating short chain fatty acid concentration

    Time frame: change from week 1-12

    measured by enzymatic kit

  14. c-reactive protein concentration

    Time frame: change from week 1-12

    measured by enzymatic kit

Other outcomes

  1. peripheral blood mononuclear cell (PBMC) telomerase activity

    Time frame: change from week 1-12

    measured by enzymatic kit

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2023
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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