Back to resultsElectrophysiological Changes With Diet.
Primary Purpose
Fasting, Intermittent, Fasting Hypoglycemia, Fasting
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Retinal electrophysiology
Sponsored by
About this trial
This is an interventional health services research trial for Fasting, Intermittent focused on measuring Fasting, Ramadan, Diet, Retina, Electroretinogram
Eligibility Criteria
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.
Sites / Locations
- Ahmed Abdelshafy TablRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intermittent fasting healthy group
Obesity group
Arm Description
Healthy participants with intermittent fasting dietary habit.
Subjects with body mass index more than 30.
Outcomes
Primary Outcome Measures
Retinal function amplitude
Changes in amplitude of retinal electrophysiology in both groups measured in nano volt/degree.
Secondary Outcome Measures
Retinal function latency.
Changes in latency of retinal electrophysiology in both groups measured in milliseconds.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05658991
Brief Title
Electrophysiological Changes With Diet.
Official Title
Retinal Functional Changes With Different Dietary Habits.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
April 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasting, Intermittent, Fasting Hypoglycemia, Fasting, Obesity, Diabetes
Keywords
Fasting, Ramadan, Diet, Retina, Electroretinogram
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intermittent fasting healthy group
Arm Type
Active Comparator
Arm Description
Healthy participants with intermittent fasting dietary habit.
Arm Title
Obesity group
Arm Type
Active Comparator
Arm Description
Subjects with body mass index more than 30.
Intervention Type
Diagnostic Test
Intervention Name(s)
Retinal electrophysiology
Intervention Description
Retinal electrophysiology to assess retinal function before and with fasting during ramadan in both groups.
Primary Outcome Measure Information:
Title
Retinal function amplitude
Description
Changes in amplitude of retinal electrophysiology in both groups measured in nano volt/degree.
Time Frame
Baseline and one month after fasting in both groups.
Secondary Outcome Measure Information:
Title
Retinal function latency.
Description
Changes in latency of retinal electrophysiology in both groups measured in milliseconds.
Time Frame
Baseline and one month after fasting in both groups.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Tabl, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Tabl, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Abdelshafy Tabl
City
Banhā
State/Province
Benha
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed A Tabl
Phone
01222328766
Email
ahmad4lg@gmail.com
Ext
Tabl
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed A Tabl, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Electrophysiological Changes With Diet.
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