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

Primary Purpose

Weight, Body

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time restircted eating
Time restricted eating + prebiotic
Control
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight, Body

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

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 At-rest blood pressure > 140/90 mg/Hg 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

Sites / Locations

  • University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Time restricted eating

TRE+Fiber

Control

Arm Description

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

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.

Individuals will eat in their normal eating pattern

Outcomes

Primary Outcome Measures

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.
acceptance of TRE in pediatric cancer survivors
TRE will be acceptable (≥ 16 on acceptability on Diet Satistfaction questionnaire).
Adherence to TRE
Adherence to TRE will be ≥ 80% throughout the intervention among participants randomized to this study arm

Secondary Outcome Measures

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).
Body composition
fat free mass and fat mass via DXA
fasting Insulin
measured by enzymatic kit (uIU/ml)^4
fasting glucose
measured by enzymatic kit (mg/dl)
HOMA-IR
fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
HbA1c
measured by enzymatic kit
Blood pressure
systolic and diastolic blood pressure with cuff
Heart rate
Heart rate measured by blood pressure cuff
Lipids (LDL, HDL, Total Choelsterol, Triglycerides)
measured by enzymatic kit
Gut microbial composition
16s RNA stool swab
Glucagon like peptide 1
measured by enzymatic kit
peptide yy
measured by enzymatic kit
circulating short chain fatty acids
measured by enzymatic kit
c-reactive protein
measured by enzymatic kit

Full Information

First Posted
April 10, 2023
Last Updated
August 28, 2023
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05826184
Brief Title
Time Restricted Eating With or Without a Fiber Supplement for Weight Management in Pediatric Cancer Survivors
Official Title
Time Restricted Eating With or Without a Fiber Supplement for Weight Management in Pediatric Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight, Body

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time restricted eating
Arm Type
Experimental
Arm Description
Individuals will eat between 12-8pm ad libitum, fasting from 8-12pm.
Arm Title
TRE+Fiber
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Individuals will eat in their normal eating pattern
Intervention Type
Behavioral
Intervention Name(s)
Time restircted eating
Intervention Description
8 hour time restricted eating alone
Intervention Type
Behavioral
Intervention Name(s)
Time restricted eating + prebiotic
Intervention Description
8 hour TRE with a prebiotic supplement
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Normal intake and timing
Primary Outcome Measure Information:
Title
feasibility of TRE in pediatric cancer survivors
Description
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.
Time Frame
1 year
Title
acceptance of TRE in pediatric cancer survivors
Description
TRE will be acceptable (≥ 16 on acceptability on Diet Satistfaction questionnaire).
Time Frame
12 weeks
Title
Adherence to TRE
Description
Adherence to TRE will be ≥ 80% throughout the intervention among participants randomized to this study arm
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
body weight (kg)
Description
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).
Time Frame
change from week 1-12
Title
Body composition
Description
fat free mass and fat mass via DXA
Time Frame
change from week 1-12
Title
fasting Insulin
Description
measured by enzymatic kit (uIU/ml)^4
Time Frame
change from week 1-12
Title
fasting glucose
Description
measured by enzymatic kit (mg/dl)
Time Frame
change from week 1-12
Title
HOMA-IR
Description
fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
Time Frame
change from week 1-12
Title
HbA1c
Description
measured by enzymatic kit
Time Frame
change from week 1-12
Title
Blood pressure
Description
systolic and diastolic blood pressure with cuff
Time Frame
change from week 1-12
Title
Heart rate
Description
Heart rate measured by blood pressure cuff
Time Frame
change from week 1-12
Title
Lipids (LDL, HDL, Total Choelsterol, Triglycerides)
Description
measured by enzymatic kit
Time Frame
change from week 1-12
Title
Gut microbial composition
Description
16s RNA stool swab
Time Frame
Change from week 1-12
Title
Glucagon like peptide 1
Description
measured by enzymatic kit
Time Frame
change from week 1-12
Title
peptide yy
Description
measured by enzymatic kit
Time Frame
change from week 1-12
Title
circulating short chain fatty acids
Description
measured by enzymatic kit
Time Frame
change from week 1-12
Title
c-reactive protein
Description
measured by enzymatic kit
Time Frame
change from week 1-12
Other Pre-specified Outcome Measures:
Title
peripheral blood mononuclear cell (PBMC) telomerase activity
Description
measured by enzymatic kit
Time Frame
change from week 1-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 At-rest blood pressure > 140/90 mg/Hg 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelsey Gabel, PhD
Phone
312-413-8911
Email
kdipma2@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelsey Gabel, PhD
Organizational Affiliation
UIC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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