Time Restricted Eating With or Without a Fiber Supplement for Weight Management in Pediatric Cancer Survivors
Study Details
Study Description
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 through this AHS Interdisciplinary grant 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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+Fiber 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
|
| Active Comparator: Control Individuals will eat in their normal eating pattern |
Behavioral: Control
Normal intake and timing
|
Outcome Measures
Primary Outcome Measures
- feasibility of TRE in pediatric cancer survivors [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.
- acceptance of TRE in pediatric cancer survivors [12 weeks]
TRE will be acceptable (≥ 16 on acceptability on Diet Satistfaction questionnaire).
- Adherence to TRE [12 weeks]
Adherence to TRE will be ≥ 80% throughout the intervention among participants randomized to this study arm
Secondary Outcome Measures
- body weight (kg) [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).
- Body composition [change from week 1-12]
fat free mass and fat mass via DXA
- fasting Insulin [change from week 1-12]
measured by enzymatic kit (uIU/ml)^4
- fasting glucose [change from week 1-12]
measured by enzymatic kit (mg/dl)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-39 years old at time of consent
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Completed anti-tumor treatment for pediatric cancer
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BMI 25-39.99 kg/m2
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Able to provide 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.
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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:
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Individuals with type 1 or 2 diabetes
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Individuals with BMI ≥ 40kg/m2 and < 25kg/m2
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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.
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Night shift workers
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Individuals with a history of eating disorders
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Active infection requiring systemic therapy
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Uncontrolled HIV/AIDS or active viral hepatitis
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Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
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Other major comorbidity, as determined by study PI
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Illicit drug use (excluding self-reported marijuana) or excessive use of alcohol (i.e., > 2 drinks/day)
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Currently participating in Weight Watcher's or another weight loss program
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At-rest blood pressure > 140/90 mg/Hg
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History of: Myocardial infarction, Stroke, Congestive heart failure, Chronic hepatitis, Cirrhosis, Chronic pancreatitis
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History of solid organ transplantation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- University of Illinois at Chicago
Investigators
- Principal Investigator: Kelsey Gabel, PhD, UIC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY2022-0745