Healthy Adult
Conditions
Brief 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 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.
Interventions
OTHERConsumption of a high fat meal
Consumption of a high fat meal: Volume 500ml, Lipid 80 % of calories
OTHERConsumption of a high carbohydrate meal
Consumption of a high carbohydrate meal: Volume 500ml, Carbohydrate 80% of calories
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Crossover study design, two separate Arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retinal vessel area density (OCTA) | 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 |
Countries
Austria
Outcome results
None listed