NCT05598515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

November 11, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2023

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

October 25, 2022

Last Update Submit

July 23, 2024

Conditions

Fanconi Anemia

Outcome Measures

Primary Outcomes (1)

  • Number of participants with neuroinflammation

    Presence of neuroinflammation will be measured with a clinical head MRI

    6 months

Study Arms (1)

Time-Restricted Feeding

EXPERIMENTAL
Behavioral: Time-Restricted Feeding

Interventions

Time-Restricted FeedingBEHAVIORAL

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

Time-Restricted Feeding

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Fanconi Anemia

Condition Hierarchy (Ancestors)

Anemia, Hypoplastic, CongenitalAnemia, AplasticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesCongenital Bone Marrow Failure SyndromesBone Marrow Failure DisordersBone Marrow DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Stella Davies, MBBS, PhD, MRCP

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 28, 2022

Study Start

November 11, 2022

Primary Completion

December 7, 2023

Study Completion

December 7, 2023

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations

US(1)