Electrophysiological Changes With Diet.

December 11, 2022 updated by: Ahmed Abdelshafy, Benha University

Retinal Functional Changes With Different Dietary Habits.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Retinal function directly related to our quality of vision, different drugs can affect our vision in certain ways, however, out unhealthy dietary habits can indirectly affect our quality of life and vision.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Benha
      • Banhā, Benha, Egypt, 13511
        • Recruiting
        • Ahmed Abdelshafy Tabl
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ahmed A Tabl, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intermittent fasting healthy group
Healthy participants with intermittent fasting dietary habit.
Diagnostic test: Retinal electrophysiology
Retinal electrophysiology to assess retinal function before and with fasting during ramadan in both groups.
Active Comparator: Obesity group
Subjects with body mass index more than 30.
Diagnostic test: Retinal electrophysiology
Retinal electrophysiology to assess retinal function before and with fasting during ramadan in both groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal function amplitude
Time Frame: Baseline and one month after fasting in both groups.
Changes in amplitude of retinal electrophysiology in both groups measured in nano volt/degree.
Baseline and one month after fasting in both groups.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal function latency.
Time Frame: Baseline and one month after fasting in both groups.
Changes in latency of retinal electrophysiology in both groups measured in milliseconds.
Baseline and one month after fasting in both groups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: Ahmed A Tabl, MD, Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2022

Primary Completion (Anticipated)

March 30, 2023

Study Completion (Anticipated)

April 20, 2023

Study Registration Dates

First Submitted

December 11, 2022

First Submitted That Met QC Criteria

December 11, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 11, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-12.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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