NCT05658991

Brief Summary

Dietary habits may affect our body by certain mechanisms, visual sense is one of the most vital human senses that needs special attention in our daily habits.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 11, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 11, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

December 11, 2022

Last Update Submit

December 11, 2022

Conditions

Fasting, IntermittentFasting HypoglycemiaFastingObesityDiabetes

Keywords

FastingRamadanDietRetinaElectroretinogram

Outcome Measures

Primary Outcomes (1)

  • Retinal function amplitude

    Changes in amplitude of retinal electrophysiology in both groups measured in nano volt/degree.

    Baseline and one month after fasting in both groups.

Secondary Outcomes (1)

  • Retinal function latency.

    Baseline and one month after fasting in both groups.

Study Arms (2)

Intermittent fasting healthy group

ACTIVE COMPARATOR

Healthy participants with intermittent fasting dietary habit.

Diagnostic Test: Retinal electrophysiology

Obesity group

ACTIVE COMPARATOR

Subjects with body mass index more than 30.

Diagnostic Test: Retinal electrophysiology

Interventions

Retinal electrophysiologyDIAGNOSTIC_TEST

Retinal electrophysiology to assess retinal function before and with fasting during ramadan in both groups.

Intermittent fasting healthy groupObesity group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects with intermittent fasting.
  • obese subjects with body mass index more than 30.

You may not qualify if:

  • patients with any retinal diseases that may ter retinal functional test.
  • patients on systemic drugs that may alter retinal function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdelshafy Tabl

Banhā, Benha, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Intermittent FastingHypoglycemiaFastingObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEndocrine System Diseases

Study Officials

  • Ahmed A Tabl, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Tabl, MD

CONTACT

01222328766ahmad4lg@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Ophthalmology

Study Record Dates

First Submitted

December 11, 2022

First Posted

December 21, 2022

Study Start

December 11, 2022

Primary Completion

March 30, 2023

Study Completion

April 20, 2023

Last Updated

December 21, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)