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Weight, BodyNCT05826184

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

A study testing Time restircted eating and Time restricted eating + prebiotic in people with Weight, Body, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Weight, Body
What is being tested?
Time restircted eating and Time restricted eating + prebiotic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
17 Nov 2023to 1 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

Other trials in United States

About this study

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
Being tested
Time restircted eating, Time restricted eating + prebiotic
Medical subject headings
Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time restircted eatingBehavioural

    8 hour time restricted eating alone

  • Time restricted eating + prebioticBehavioural

    8 hour TRE with a prebiotic supplement

Study groups in NCT05826184
Study groupRoleWhat they receive
Time restricted eatingExperimentalIndividuals will eat between 12-8pm ad libitum, fasting from 8-12pm.
Receives: Behavioral: Time restircted eating
TRE+ prebiotic supplementExperimentalIndividuals 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.
Receives: Behavioral: Time restricted eating + prebiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. acceptance of TRE in pediatric cancer survivors

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

    Measured: 12 weeks

  3. Adherence to TRE

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

    Measured: 12 weeks

Secondary outcomes (14)

  1. 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).

    Measured: change from week 1-12

  2. Body composition

    fat free mass and fat mass via DXA

    Measured: change from week 1-12

  3. fasting Insulin

    measured by enzymatic kit (uIU/ml)^4

    Measured: change from week 1-12

  4. fasting glucose

    measured by enzymatic kit (mg/dl)

    Measured: change from week 1-12

  5. insulin resistance change

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

    Measured: change from week 1-12

  6. Hemoglobin A1c concentration

    measured by enzymatic kit

    Measured: change from week 1-12

  7. Blood pressure

    systolic and diastolic blood pressure with cuff

    Measured: change from week 1-12

  8. Heart rate

    Heart rate measured by blood pressure cuff

    Measured: change from week 1-12

  9. Lipid concentration

    measured by enzymatic kit

    Measured: change from week 1-12

  10. Gut microbial composition

    16s RNA stool swab

    Measured: Change from week 1-12

  11. Glucagon like peptide 1 concentration

    measured by enzymatic kit

    Measured: change from week 1-12

  12. peptide yy concentration

    measured by enzymatic kit

    Measured: change from week 1-12

  13. circulating short chain fatty acid concentration

    measured by enzymatic kit

    Measured: change from week 1-12

  14. c-reactive protein concentration

    measured by enzymatic kit

    Measured: change from week 1-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2023
  2. Study start17 Nov 2023
  3. Primary completion1 Jul 2025
  4. Study completion1 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05826184
Sponsor's protocol ID
STUDY2022-0745
Status last verified
Feb 2025
First submitted
10 Apr 2023
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Time restircted eating and Time restricted eating + prebiotic in people with Weight, Body, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

feasibility of TRE in pediatric cancer survivors (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05826184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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