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CompletedNCT05598515Updated Jul 24, 2024

Time-restricted Feeding to Reduce Inflammation in Fanconi Anemia

An interventional study of Time-Restricted Feeding in Fanconi Anemia, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-07-24.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study summary

The main reason for this research study is to determine whether time-restricted eating will reduce inflammation in the bodies of persons with Fanconi anemia (FA) and whether time-restricted eating will improve function in people with FA and neurological changes. Participants will be asked to eat for only 8 hours out of 24 hours in a day.

02

Conditions studied

  • Fanconi Anemia

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03

In context

Fanconi Anemia

101 studies on the registry are indexed under Fanconi Anemia; 22 are open to participants now.

This study's enrollment of 3 is below the median of 19 across 60 interventional studies indexed under Fanconi Anemia.

Browse Fanconi Anemia studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 133 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 31 (55%) have results posted.

Browse Children's Hospital Medical Center, Cincinnati studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of FA with neuroinflammation
  • Age ≥ 12 years old

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Time-Restricted Feeding

    Behavioral: Time-Restricted Feeding

Interventions

  • BehavioralTime-Restricted Feeding

    Participants will be asked to eat for only 8 hours out of 24 hours in a day.

06

What researchers measure

Primary outcomes

  1. Number of participants with neuroinflammation

    Presence of neuroinflammation will be measured with a clinical head MRI

    Time frame: 6 months

07

Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2022 to primary completion in Dec 2023, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2022
First posted
Oct 28, 2022
StartActual
Nov 11, 2022
Primary completionActual
Dec 7, 2023
CompletionActual
Dec 7, 2023
Last update
Jul 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05598515
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Responsible party
Sponsor
First posted
Oct 28, 2022
Start date
Nov 11, 2022
Primary completion
Dec 7, 2023
Completion
Dec 7, 2023
Last update
Jul 24, 2024

Study contacts

Stella Davies, MBBS, PhD, MRCP
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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