Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients

Hematopoietic Stem Cell Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04549038
• Other study ID #: 2019-1180
• Status: Completed
• Phase: N/A
• Start date: May 19, 2020
• Est. completion date: November 18, 2022

Study information

• Verified date: February 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 18, 2022
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplant

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

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