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

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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic Stem Cell Transplant
• Intervention / Treatment: Other: 12-16 hour nutrition

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cases; 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; 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.
NO_INTERVENTION: Controls; 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?

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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Christopher Dandoy, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 19, 2020
• Primary Completion (ACTUAL): August 25, 2022
• Study Completion (ACTUAL): November 18, 2022

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (ACTUAL): September 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2019-1180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No