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OpenTrials
Completed

NCT Number: NCT04549038

Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplant

Age range

12 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

12-16 hour nutrition

Other

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.

Primary outcomes

  1. Number of wake episodes

    Time frame: 21 days

    Number of wake episodes

  2. Duration of wake episodes

    Time frame: 21 days

    Duration of wake episodes

Secondary outcomes

  1. Hypertension

    Time frame: 21 days

    Incidence of hypertension

  2. Weight change

    Time frame: 21 days

    Change in weight at day +7, +14, and +21 from day 0

  3. Time to tolerating oral feeds

    Time frame: 21 days

    Number of days post-transplant until the patient tolerates feeds/nutrition

  4. Neutrophil engraftment

    Time frame: 21 days

    Time to absolute neutrophil count >500

  5. Cortisol levels

    Time frame: 21 days

    3 times weekly morning cortisol levels

  6. Triglyceride levels

    Time frame: 21 days

    Weekly triglyceride levels

  7. Glucose levels

    Time frame: 21 days

    Daily glucose levels

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2020
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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