Time Restricted Eating With or Without a Fiber Supplement for Weight Management in Pediatric Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- feasibility of TRE in pediatric cancer survivors
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
feasibility of TRE in pediatric cancer survivors
时间窗: 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.
Adherence to TRE
时间窗: 12 weeks
Adherence to TRE will be ≥ 80% throughout the intervention among participants randomized to this study arm
acceptance of TRE in pediatric cancer survivors
时间窗: 12 weeks
TRE will be acceptable (≥ 16 on acceptability on Diet Satistfaction questionnaire).
次要结局
- Heart rate(change from week 1-12)
- fasting glucose(change from week 1-12)
- Hemoglobin A1c concentration(change from week 1-12)
- Blood pressure(change from week 1-12)
- body weight (kg)(change from week 1-12)
- Body composition(change from week 1-12)
- fasting Insulin(change from week 1-12)
- insulin resistance change(change from week 1-12)
- Lipid concentration(change from week 1-12)
- Gut microbial composition(Change from week 1-12)
- Glucagon like peptide 1 concentration(change from week 1-12)
- peptide yy concentration(change from week 1-12)
- circulating short chain fatty acid concentration(change from week 1-12)
- c-reactive protein concentration(change from week 1-12)
研究者
Kelsey Nicole Dipman Gabel
Clinial Assistant Professor and Postdoctoral Researcher
University of Illinois at Chicago