- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati CHildren's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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
Time Frame: 21 days
|
Number of wake episodes
|
21 days
|
Duration of wake episodes
Time Frame: 21 days
|
Duration of wake episodes
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypertension
Time Frame: 21 days
|
Incidence of hypertension
|
21 days
|
Weight change
Time Frame: 21 days
|
Change in weight at day +7, +14, and +21 from day 0
|
21 days
|
Time to tolerating oral feeds
Time Frame: 21 days
|
Number of days post-transplant until the patient tolerates feeds/nutrition
|
21 days
|
Neutrophil engraftment
Time Frame: 21 days
|
Time to absolute neutrophil count >500
|
21 days
|
Cortisol levels
Time Frame: 21 days
|
3 times weekly morning cortisol levels
|
21 days
|
Triglyceride levels
Time Frame: 21 days
|
Weekly triglyceride levels
|
21 days
|
Glucose levels
Time Frame: 21 days
|
Daily glucose levels
|
21 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christopher Dandoy, Children's Hospital Medical Center, Cincinnati
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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