Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients

Study Overview
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Brief Summary
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Circadian cycles, metabolism, and nutrition are intimately linked, and the timing of meals play an important role in synchronizing peripheral circadian rhythms. There are little data describing the influence of nocturnal feeds on sleep, metabolism, and overall health in hospitalized children. To evaluate this association, the investigators will conduct a single-center, randomized, non-blinded controlled trial that will test the impact of nocturnal enteral/parenteral nutrition on patient outcomes.

Detailed Description
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HSCT provides a potential cure for children and adults with high risk and relapsed malignancy, immune deficiency, and other fatal illnesses. Circadian cycles, metabolism, and nutrition are intimately linked, and the timing of meals play an important role in synchronizing peripheral circadian rhythms; however, the standard of care for HSCT recipients is to deliver continuous feeds (either enterally or parenterally). The objective of this study is to evaluate the influence of the timing of feeding on sleep and metabolism in HSCT subjects. The investigators hypothesize patients receiving feeds during daytime hours (0800-2000) in comparison to continuous (24 hours), will have improved sleep efficiency, decreased blood glucose, insulin, and triglycerides over patients who receive feeding overnight. The aim of this study is to evaluate the influence of the timing of feeds on sleep, metabolism, and outcomes in HSCT subjects.

Official Title
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Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients: Impact on Circadian Rhythm, Insulin Regulation, and Outcomes

Conditions
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Hematopoietic Stem Cell Transplant

Intervention / Treatment
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* Other: 12-16 hour nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients >/= 12 months of age undergoing HSCT and receiving a myeloablative preparative regimen Exclusion Criteria: Prior history of hypoglycemia, diabetes mellitus, metabolic disease, or other requirement for continuous nutrition

Ages Eligible for Study
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Minimum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomized, non-blinded, controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cases<br>Patients randomized to the cases group will receive their nutrition over a period of 12-16 hours, with minimum 8 hours of fasting and maximum 12 hours of fasting. All patients will receive 100% of their daily nutrition. | Other: 12-16 hour nutrition<br>* Cases will receive their nutrition over a period of 12-16 hours, with minimum 8 hours of fasting and maximum 12 hours of fasting. Feeding will begin in morning hours unless otherwise directed by an investigator or registered dietician.<br>|
| No Intervention: Controls<br>Patients randomized to the control group will receive the current standard of care (24-hour continuous nutrition). All patients will receive 100% of their daily nutrition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of wake episodes | Number of wake episodes | 21 days | 
| Duration of wake episodes | Duration of wake episodes | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension | Incidence of hypertension | 21 days | 
| Weight change | Change in weight at day +7, +14, and +21 from day 0 | 21 days | 
| Time to tolerating oral feeds | Number of days post-transplant until the patient tolerates feeds/nutrition | 21 days | 
| Neutrophil engraftment | Time to absolute neutrophil count >500 | 21 days | 
| Cortisol levels | 3 times weekly morning cortisol levels | 21 days | 
| Triglyceride levels | Weekly triglyceride levels | 21 days | 
| Glucose levels | Daily glucose levels | 21 days |