NCT04549038

Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Hematopoietic Stem Cell Transplant

Interventions

Type	Name	Description
OTHER	12-16 hour nutrition	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.

Timeline

• Start date: 2020-05-19
• Primary completion: 2022-08-25
• Completion: 2022-11-18
• First posted: 2020-09-16
• Last updated: 2023-02-08

Locations

1 site across 1 country: United States