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

Weight, Body Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826184
• Other study ID #: STUDY2022-0745
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: November 16, 2024

Study information

• Verified date: November 2023
• Source: University of Illinois at Chicago
• Contact: Kelsey Gabel, PhD
• Phone: 312-413-8911
• Email: kdipma2[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 16, 2024
• Est. primary completion date: November 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight, Body

Intervention

Behavioral:
• Time restircted eating
8 hour time restricted eating alone
• Time restricted eating + prebiotic
8 hour TRE with a prebiotic supplement

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	peripheral blood mononuclear cell (PBMC) telomerase activity	measured by enzymatic kit	change from week 1-12
Primary	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
Primary	acceptance of TRE in pediatric cancer survivors	TRE will be acceptable (= 16 on acceptability on Diet Satistfaction questionnaire).	12 weeks
Primary	Adherence to TRE	Adherence to TRE will be = 80% throughout the intervention among participants randomized to this study arm	12 weeks
Secondary	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
Secondary	Body composition	fat free mass and fat mass via DXA	change from week 1-12
Secondary	fasting Insulin	measured by enzymatic kit (uIU/ml)^4	change from week 1-12
Secondary	fasting glucose	measured by enzymatic kit (mg/dl)	change from week 1-12
Secondary	insulin resistance change	fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.	change from week 1-12
Secondary	Hemoglobin A1c concentration	measured by enzymatic kit	change from week 1-12
Secondary	Blood pressure	systolic and diastolic blood pressure with cuff	change from week 1-12
Secondary	Heart rate	Heart rate measured by blood pressure cuff	change from week 1-12
Secondary	Lipid concentration	measured by enzymatic kit	change from week 1-12
Secondary	Gut microbial composition	16s RNA stool swab	Change from week 1-12
Secondary	Glucagon like peptide 1 concentration	measured by enzymatic kit	change from week 1-12
Secondary	peptide yy concentration	measured by enzymatic kit	change from week 1-12
Secondary	circulating short chain fatty acid concentration	measured by enzymatic kit	change from week 1-12
Secondary	c-reactive protein concentration	measured by enzymatic kit	change from week 1-12