Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients

Not Applicable

Completed

• Conditions: Hematopoietic Stem Cell Transplant
• Interventions: Other: 12-16 hour nutrition

• Registration Number: NCT04549038
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study Start: 2020-05-19
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-16
• Primary Completion: 2022-08-25
• Study Completion: 2022-11-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cases	12-16 hour nutrition	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.

Primary Outcome Measures

Name	Time	Method
Number of wake episodes	21 days	Number of wake episodes
Duration of wake episodes	21 days	Duration of wake episodes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States