Fasting, IntermittentNCT05658991
Electrophysiological Changes With Diet.
A study testing Retinal electrophysiology in people with Fasting, Intermittent and Fasting Hypoglycemia, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting, Intermittent, Fasting Hypoglycemia, Fasting
- What is being tested?
- Retinal electrophysiology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Dec 2022to 20 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects with intermittent fasting.
- obese subjects with body mass index more than 30.
Who cannot join
- patients with any retinal diseases that may ter retinal functional test.
- patients on systemic drugs that may alter retinal function.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy Tabl
Banhā, Benha, 13511
Ahmed A Tabl, 01222328766, ahmad4lg@gmail.com
ahmad4lg@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Fasting, Intermittent, Fasting Hypoglycemia, Fasting, Obesity, Diabetes
- Being tested
- Retinal electrophysiology
- Keywords
- Fasting, Ramadan, Diet, Retina, Electroretinogram
- Medical subject headings
- Intermittent Fasting, Hypoglycemia, Fasting, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal electrophysiologyDiagnostic test
Retinal electrophysiology to assess retinal function before and with fasting during ramadan in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting healthy group | Active comparator | Healthy participants with intermittent fasting dietary habit. Receives: Diagnostic Test: Retinal electrophysiology |
| Obesity group | Active comparator | Subjects with body mass index more than 30. Receives: Diagnostic Test: Retinal electrophysiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal function amplitude
Changes in amplitude of retinal electrophysiology in both groups measured in nano volt/degree.
Measured: Baseline and one month after fasting in both groups.
Secondary outcomes (1)
Retinal function latency.
Changes in latency of retinal electrophysiology in both groups measured in milliseconds.
Measured: Baseline and one month after fasting in both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start11 Dec 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion20 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasting, IntermittentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Ahmed A Tabl, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658991
- Sponsor's protocol ID
- RC-12.2022
- Status last verified
- Dec 2022
- First submitted
- 11 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Functional Changes With Different Dietary Habits.
- ClinicalTrials.gov ID
- NCT05658991
- Acronym / sponsor ID
- RC-12.2022
- Conditions
- Fasting, Intermittent, Fasting Hypoglycemia, Fasting, Obesity, Diabetes
- Keywords
- Fasting, Ramadan, Diet, Retina, Electroretinogram
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 11 Dec 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 20 Apr 2023 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting healthy group | Active comparator | Diagnostic Test: Retinal electrophysiologyHealthy participants with intermittent fasting dietary habit. |
| Obesity group | Active comparator | Diagnostic Test: Retinal electrophysiologySubjects with body mass index more than 30. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy subjects with intermittent fasting.
- obese subjects with body mass index more than 30.
Key exclusion criteria (2 listed)
- patients with any retinal diseases that may ter retinal functional test.
- patients on systemic drugs that may alter retinal function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retinal electrophysiologyRetinal electrophysiology to assess retinal function before and with fasting during ramadan in both groups. | Diagnostic test | Intermittent fasting healthy group, Obesity group |
Primary outcome
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.
1 secondary outcome
Retinal function latency.
Time frame: Baseline and one month after fasting in both groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A Tabl, MD principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retinal electrophysiology in people with Fasting, Intermittent and Fasting Hypoglycemia, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Tabl, MD (01222328766, ahmad4lg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal function amplitude (time frame: Baseline and one month after fasting in both groups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.