Time-restricted Feeding to Reduce Inflammation in Fanconi Anemia
Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Recruiting
CT.gov ID
NCT05598515
Collaborator
(none)
10
1
1
34.7
0.3
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Single Arm Prospective Trial of Time-restricted Feeding to Reduce Inflammation in Fanconi Anemia
Actual Study Start Date
:
Nov 11, 2022
Anticipated Primary Completion Date
:
Oct 1, 2025
Anticipated Study Completion Date
:
Oct 1, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Time-Restricted Feeding
|
Behavioral: Time-Restricted Feeding
Participants will be asked to eat for only 8 hours out of 24 hours in a day.
|
Outcome Measures
Primary Outcome Measures
- Number of participants with neuroinflammation [6 months]
Presence of neuroinflammation will be measured with a clinical head MRI
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of FA with neuroinflammation
-
Age ≥ 12 years old
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
Sponsors and Collaborators
- Children's Hospital Medical Center, Cincinnati
Investigators
- Principal Investigator: Stella Davies, MBBS, PhD, MRCP, Children's Hospital Medical Center, Cincinnati
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT05598515
Other Study ID Numbers:
- 2022-0751
First Posted:
Oct 28, 2022
Last Update Posted:
Nov 28, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: