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Time Restricted Eating + Prebiotic for Obesity
N/A
Recruiting
Led By Kelsey Gabel, PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to use innovative solutions to improve the health of pediatric cancer survivors by exploring the effects of nutrition therapy on weight, body composition, glucose regulation, and cardiovascular risk. It will provide important evidence of the benefits of nutrition therapy for young adult survivors.
Who is the study for?
This trial is for young adult pediatric cancer survivors aged 18-39 with a BMI of 25-39.99 kg/m2 who have completed their anti-tumor treatment. It's not for those with diabetes, severe obesity or underweight, pregnant or breastfeeding women, night shift workers, individuals with certain medical conditions that prevent informed consent or participation in the trial.
What is being tested?
The study tests time-restricted eating (TRE) alone and TRE combined with a prebiotic fiber supplement to manage weight and improve health outcomes like body composition and cardiovascular risk markers in pediatric cancer survivors.
What are the potential side effects?
Potential side effects are not explicitly listed but may include changes in digestion due to dietary adjustments and prebiotic intake. The safety profile will be closely monitored given the participants' survivorship status.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence to TRE
acceptance of TRE in pediatric cancer survivors
feasibility of TRE in pediatric cancer survivors
Secondary study objectives
Blood pressure
Body composition
Glucagon like peptide 1 concentration
+11 moreOther study objectives
peripheral blood mononuclear cell (PBMC) telomerase activity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Time restricted eatingExperimental Treatment1 Intervention
Individuals will eat between 12-8pm ad libitum, fasting from 8-12pm.
Group II: TRE+ prebiotic supplementExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,569,106 Total Patients Enrolled
37 Trials studying Obesity
10,306 Patients Enrolled for Obesity
Kelsey Gabel, PhDPrincipal InvestigatorUIC
1 Previous Clinical Trials
17 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart issues, stroke, or chronic liver/pancreas conditions.I am currently on medication for an infection.I am taking medication to control my blood sugar levels.I've lost 3% or more of my weight in the last 3 months through a program.I understand and can follow the study's procedures.My BMI is between 25 and 40.I am mentally and physically able to participate in a clinical trial.I am either younger than 18 or older than 39 years old.I do not have uncontrolled HIV/AIDS or active hepatitis.I have not taken antibiotics in the last 2 months.I have finished treatment for childhood cancer.I have had a solid organ transplant.I am between 18 and 39 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Time restricted eating
- Group 2: TRE+ prebiotic supplement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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