Chocolate Dynamic Vessel Analysis

Retinal Vascular Clinical Trial

Official title:

Evaluation of the Effects of Chocolate on Anatomy and Functionality of Retinal Blood Vessels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05227248
• Other study ID #: FondazioneSanRaffaele
• Status: Completed
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: July 13, 2021

Study information

• Verified date: February 2022
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims at evaluating the effect of dark chocolate consumption on anatomy and functionality of retinal blood vessels by comparing these same parameters after milk chocolate consumption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 13, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age of 18 years or older
• Healthy volunteers
• No vascular diseases
• No ocular diseases
• Volunteers capable of understanding informed consent

Exclusion Criteria:

• Patient unable to follow the instructions
• Patient unable to come back for follow-up
• opacity of lens, cornea, or vitreous
• Allergies that contraindicate pupil dilation
• Eye diseases
• Myopia greater than -8.0 Diopter (D),
• Hyperopia greater than 5.0 D
• Astigmatism greater than -3.0 D

Related Conditions & MeSH terms

• Retinal Vascular

Intervention

Dietary Supplement:
• Dark chocolate
Patients were administered 20 grams of dark chocolate
• Milk Chocolate
Patients were administered 7.5 grams of milk chocolate

Locations

Country	Name	City	State
Italy	Giuseppe Querques	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Querques Giuseppe

Country where clinical trial is conducted

Italy, 

References & Publications (5)

de Carlo TE, Romano A, Waheed NK, Duker JS. A review of optical coherence tomography angiography (OCTA). Int J Retina Vitreous. 2015 Apr 15;1:5. eCollection 2015. Review. — View Citation

Huang Y, Zhang Q, Thorell MR, An L, Durbin MK, Laron M, Sharma U, Gregori G, Rosenfeld PJ, Wang RK. Swept-source OCT angiography of the retinal vasculature using intensity differentiation-based optical microangiography algorithms. Ophthalmic Surg Lasers Imaging Retina. 2014 Sep-Oct;45(5):382-9. — View Citation

McClintic SM, Jia Y, Huang D, Bailey ST. Optical coherence tomographic angiography of choroidal neovascularization associated with central serous chorioretinopathy. JAMA Ophthalmol. 2015 Oct;133(10):1212-4. doi: 10.1001/jamaophthalmol.2015.2126. — View Citation

Rabin JC, Karunathilake N, Patrizi K. Effects of Milk vs Dark Chocolate Consumption on Visual Acuity and Contrast Sensitivity Within 2 Hours: A Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jun 1;136(6):678-681. doi: 10.1001/jamaophthalmol.2018.0978. — View Citation

Siedlecki J, Mohr N, Luft N, Schworm B, Keidel L, Priglinger SG. Effects of Flavanol-Rich Dark Chocolate on Visual Function and Retinal Perfusion Measured With Optical Coherence Tomography Angiography: A Randomized Clinical Trial. JAMA Ophthalmol. 2019 Dec 1;137(12):1373-1379. doi: 10.1001/jamaophthalmol.2019.3731. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal perfusion	Changes in retinal perfusion using Optical Coherence Tomography Angiography	Baseline, 2 hours after intervention
Primary	Retinal vascular response	Changes in retinal vascular response to flicker stimulation using Dynamic Vessels Analysis and Retinal Vessels Analysis	Baseline, 2 hours after intervention
Secondary	Visual Acuity	Best Corrected Visual Acuity changes	Baseline, 2 hours after intervention

External Links

•   Nutrition Foundation of Italy