Time-restricted Feeding to Reduce Inflammation in Fanconi... | NCT05598515

Studies
Time-restricted Feeding to Reduce Inflammation in Fanconi Anemia

NCT05598515

Sponsor

Children's Hospital Medical Center, Cincinnati

Status

Completed

Last Update Posted

Jul 24, 2024Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Fanconi Anemia

Interventions

Time-Restricted Feeding

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2022Actual

Primary Completion Date

Dec 7, 2023Actual

Completion Date

Dec 7, 2023Actual

First Submitted Date

Oct 25, 2022

First Submission Date that Met QC Criteria

Oct 25, 2022

First Posted Date

Oct 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2024

Last Update Posted Date

Jul 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Time-Restricted Feeding	Experimental		Behavioral: Time-Restricted Feeding

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Time-Restricted Feeding	Behavioral	Participants will be asked to eat for only 8 hours out of 24 hours in a day.	Time-Restricted Feeding

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with neuroinflammation	Presence of neuroinflammation will be measured with a clinical head MRI	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of FA with neuroinflammation
Age ≥ 12 years old

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stella Davies, MBBS, PhD, MRCP	Children's Hospital Medical Center, Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center		Cincinnati	Ohio	45229	United States

Condition Browse Module

MeSH Terms

ID	Term
D005199	Fanconi Anemia

Ancestor Terms

ID	Term
D029502	Anemia, Hypoplastic, Congenital
D000741	Anemia, Aplastic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided