Healthy AdultNCT07818239
Optical Imaging of Retinal Vascular Metrics Under Different Dietary Conditions
A study testing Consumption of a high fat meal and Consumption of a high carbohydrate meal in people with Healthy Adult, run by Medical University of Vienna at 1 site in Austria.
Trial summary
In a typical clinical setting, patient eating habits are not controlled when performing optical coherence tomography (OCT) imaging for retinal diagnostics. Nevertheless, the timing of the patient's most recent meal has the potential to impact OCT metrics particularly for those involving blood vessels, such as vascular… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Consumption of a high fat meal and Consumption of a high carbohydrate meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years
- Signed informed consent
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings
Who cannot join
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition as judged by the clinical investigator
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except hormonal contraceptives)
- Untreated arterial hypertension (defined as either systolic blood pressure >150 mmHg or diastolic blood pressure >95 mmHg)
- Blood donation during the previous three weeks
- Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- Pregnancy, planned pregnancy or lactating
- Lactose intolerance or other relevant food allergy or sensitivity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna
About this study
In a typical clinical setting, patient eating habits are not controlled when performing optical coherence tomography (OCT) imaging for retinal diagnostics. Nevertheless, the timing of the patient's most recent meal has the potential to impact OCT metrics particularly for those involving blood vessels, such as vascular density. Studies have shown that eating a high fat meal can increase blood fat levels in the hours following the meal. In particular, chylomicrons, the fat particles that will most likely affect the OCT signal, peak in concentration about 2-3 hours after eating. Preclinical animal studies have shown that intravascular injections of fat emulsions in rodent models can cause an increase in OCT signal and make blood vessels more visible. This study investigates the impact of a single high fat meal on OCT and OCT angiography (OCTA) measurements of retinal vessels and whether these effects differ from the effects of a single low-fat, high carbohydrate meal.
- Conditions
- Healthy Adult
- Being tested
- Consumption of a high fat meal, Consumption of a high carbohydrate meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of a high fat mealOther
Consumption of a high fat meal: Volume 500ml, Lipid 80 % of calories
Consumption of a high carbohydrate mealOther
Consumption of a high carbohydrate meal: Volume 500ml, Carbohydrate 80% of calories
| Study group | Role | What they receive |
|---|---|---|
| High carbohydrate | Active comparator | Not described Receives: Other: Consumption of a high fat meal; Other: Consumption of a high carbohydrate meal |
| High fat | Active comparator | Not described Receives: Other: Consumption of a high fat meal; Other: Consumption of a high carbohydrate meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal vessel area density (OCTA)
Retinal vessel area density measured by OCTA
Measured: On both study days, from the start of the meal consumption every 30 min up to 5 hours after meal consumption; BL, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Sep 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover study design, two separate Arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doreen Schmidl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818239
- Sponsor's protocol ID
- OPHT-20260601
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Imaging of Retinal Vascular Metrics Under Different Dietary Conditions
- ClinicalTrials.gov ID
- NCT07818239
- Acronym / sponsor ID
- OPHT-20260601
- Conditions
- Healthy Adult
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 14 Sep 2026 (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.
In a typical clinical setting, patient eating habits are not controlled when performing optical coherence tomography (OCT) imaging for retinal diagnostics. Nevertheless, the timing of the patient's most recent meal has the potential to impact OCT metrics particularly for those involving blood vessels, such as vascular density. Studies have shown that eating a high fat meal can increase blood fat levels in the hours following the meal. In particular, chylomicrons, the fat particles that will most likely affect the OCT signal, peak in concentration about 2-3 hours after eating. Preclinical animal studies have shown that intravascular injections of fat emulsions in rodent models can cause an increase in OCT signal and make blood vessels more visible. This study investigates the impact of a single high fat meal on OCT and OCT angiography (OCTA) measurements of retinal vessels and whether these effects differ from the effects of a single low-fat, high carbohydrate meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover study design, two separate Arms
| Arm | Type | Receives |
|---|---|---|
| High carbohydrate | Active comparator | Other: Consumption of a high fat meal, Other: Consumption of a high carbohydrate meal |
| High fat | Active comparator | Other: Consumption of a high fat meal, Other: Consumption of a high carbohydrate meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged over 18 years
- Signed informed consent
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings
Key exclusion criteria (8 listed)
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition as judged by the clinical investigator
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except hormonal contraceptives)
- Untreated arterial hypertension (defined as either systolic blood pressure >150 mmHg or diastolic blood pressure >95 mmHg)
- Blood donation during the previous three weeks
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 |
|---|---|---|
| Consumption of a high fat mealConsumption of a high fat meal: Volume 500ml, Lipid 80 % of calories | Other | High carbohydrate, High fat |
| Consumption of a high carbohydrate mealConsumption of a high carbohydrate meal: Volume 500ml, Carbohydrate 80% of calories | Other | High carbohydrate, High fat |
Primary outcome
Retinal vessel area density (OCTA)
Time frame: On both study days, from the start of the meal consumption every 30 min up to 5 hours after meal consumption; BL, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min
Retinal vessel area density measured by OCTA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of a high fat meal and Consumption of a high carbohydrate meal in people with Healthy Adult, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 14 Sep 2026. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal vessel area density (OCTA) (time frame: On both study days, from the start of the meal consumption every 30 min up to 5 hours after meal consumption; BL, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min). 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 14 Sep 2026.