Chocolate Dynamic Vessel Analysis

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

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.

Study Overview

• Status: Completed
• Conditions: Retinal Vascular
• Intervention / Treatment: Dietary supplement: Dark chocolate; Dietary supplement: Milk Chocolate

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20134
    • Giuseppe Querques

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Main study arm; Patients received intervention 1 and then intervention 2 after 7 weeks	Dietary supplement: Dark chocolate; Patients were administered 20 grams of dark chocolate; Dietary supplement: Milk Chocolate; Patients were administered 7.5 grams of milk chocolate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal perfusion	Changes in retinal perfusion using Optical Coherence Tomography Angiography	Baseline, 2 hours after intervention
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Best Corrected Visual Acuity changes	Baseline, 2 hours after intervention

Collaborators and Investigators

• Sponsor: Querques Giuseppe
• Investigators: Principal Investigator: Francesco Bandello, MD, Ospedale San Raffaele

Publications and helpful links

General Publications

• 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. doi: 10.1186/s40942-015-0005-8. eCollection 2015.
• 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. doi: 10.3928/23258160-20140909-08.
• 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. No abstract available.
• 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.
• 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.

Helpful Links

• Nutrition Foundation of Italy

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 9, 2021
• Primary Completion (ACTUAL): July 13, 2021
• Study Completion (ACTUAL): July 13, 2021

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (ACTUAL): February 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 6, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: FondazioneSanRaffaele

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No