Hematopoietic Stem Cell TransplantNCT04549038
Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients
A study testing 12-16 hour nutrition in people with Hematopoietic Stem Cell Transplant, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplant
- What is being tested?
- 12-16 hour nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2020to 18 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients >/= 12 months of age undergoing HSCT and receiving a myeloablative preparative regimen
Who cannot join
- Prior history of hypoglycemia, diabetes mellitus, metabolic disease, or other requirement for continuous nutrition
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
About this study
Official title: 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.
Read the 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.
- Conditions
- Hematopoietic Stem Cell Transplant
- Being tested
- 12-16 hour nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-16 hour nutritionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Experimental | 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. Receives: Other: 12-16 hour nutrition |
| Controls | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of wake episodes
Number of wake episodes
Measured: 21 days
Duration of wake episodes
Duration of wake episodes
Measured: 21 days
Secondary outcomes (7)
Hypertension
Incidence of hypertension
Measured: 21 days
Weight change
Change in weight at day +7, +14, and +21 from day 0
Measured: 21 days
Time to tolerating oral feeds
Number of days post-transplant until the patient tolerates feeds/nutrition
Measured: 21 days
Neutrophil engraftment
Time to absolute neutrophil count >500
Measured: 21 days
Cortisol levels
3 times weekly morning cortisol levels
Measured: 21 days
Triglyceride levels
Weekly triglyceride levels
Measured: 21 days
Glucose levels
Daily glucose levels
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start19 May 2020
- Primary completion25 Aug 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomized, non-blinded, controlled
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Dandoy, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549038
- Sponsor's protocol ID
- 2019-1180
- Status last verified
- Feb 2023
- First submitted
- 8 Sep 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients: Impact on Circadian Rhythm, Insulin Regulation, and Outcomes
- ClinicalTrials.gov ID
- NCT04549038
- Acronym / sponsor ID
- 2019-1180
- Conditions
- Hematopoietic Stem Cell Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 19 May 2020 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomized, non-blinded, controlled
| Arm | Type | Receives |
|---|---|---|
| Cases | Experimental | Other: 12-16 hour nutritionPatients 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. |
| Controls | No intervention | –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. |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients >/= 12 months of age undergoing HSCT and receiving a myeloablative preparative regimen
Key exclusion criteria (1 listed)
- Prior history of hypoglycemia, diabetes mellitus, metabolic disease, or other requirement for continuous nutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-16 hour nutritionCases 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. | Other | Cases |
Primary outcome
Number of wake episodes
Time frame: 21 days
Number of wake episodes
Duration of wake episodes
Time frame: 21 days
Duration of wake episodes
7 secondary outcomes
Hypertension
Time frame: 21 days
Weight change
Time frame: 21 days
Time to tolerating oral feeds
Time frame: 21 days
Neutrophil engraftment
Time frame: 21 days
Cortisol levels
Time frame: 21 days
Triglyceride levels
Time frame: 21 days
Glucose levels
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Dandoy principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-16 hour nutrition in people with Hematopoietic Stem Cell Transplant, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of wake episodes (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.