Clinical trial NCT04549038: Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients
Official title: Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients: Impact on Circadian Rhythm, Insulin Regulation, and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplant
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 21
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomized, non-blinded, controlled
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of wake episodes
timeFrame: 21 days
measure: Duration of wake episodes
timeFrame: 21 days
Secondary outcomes:
measure: Hypertension
timeFrame: 21 days
measure: Weight change
timeFrame: 21 days
measure: Time to tolerating oral feeds
timeFrame: 21 days
measure: Neutrophil engraftment
timeFrame: 21 days
measure: Cortisol levels
timeFrame: 21 days
measure: Triglyceride levels
timeFrame: 21 days
measure: Glucose levels
timeFrame: 21 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Christopher Dandoy
role: PRINCIPAL_INVESTIGATOR
References: