Optical Imaging of Retinal Vascular Metrics Under Different Dietary Conditions

NCT07818239 | Enrolling By Invitation

• 1 other identifier: OPHT-20260601
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (1)

• Retinal vessel area density (OCTA)

  Retinal vessel area density measured by 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

Study Arms (2)

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

Interventions

Consumption of a high fat meal OTHER

Consumption of a high fat meal: Volume 500ml, Lipid 80 % of calories

High carbohydrate; High fat

Consumption of a high carbohydrate meal OTHER

Consumption of a high carbohydrate meal: Volume 500ml, Carbohydrate 80% of calories

High carbohydrate; High fat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc-Prof. Priv.-Doz. Dr.med.univ.; PhD

Model Details: Crossover study design, two separate Arms

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 14, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

AU (1)