Chocolate Dynamic Vessel Analysis

• Sponsor: Querques Giuseppe (Other)
• Overall Status: Completed
• CT.gov ID: NCT05227248
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.1
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Vascular	Dietary Supplement: Dark chocolate; Dietary Supplement: Milk Chocolate	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of the Effects of Chocolate on Anatomy and Functionality of Retinal Blood Vessels
• Actual Study Start Date: Apr 9, 2021
• Actual Primary Completion Date: Jul 13, 2021
• Actual Study Completion Date: Jul 13, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Retinal perfusion [Baseline, 2 hours after intervention]

   Changes in retinal perfusion using Optical Coherence Tomography Angiography

2. Retinal vascular response [Baseline, 2 hours after intervention]

   Changes in retinal vascular response to flicker stimulation using Dynamic Vessels Analysis and Retinal Vessels Analysis

Secondary Outcome Measures

1. Visual Acuity [Baseline, 2 hours after intervention]

   Best Corrected Visual Acuity changes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Giuseppe Querques	Milan		Italy	20134

Sponsors and Collaborators

• Querques Giuseppe

Investigators

• Principal Investigator: Francesco Bandello, MD, Ospedale San Raffaele

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Nutrition Foundation of Italy

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. eCollection 2015. Review.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Querques Giuseppe, Professor, Ospedale San Raffaele
• ClinicalTrials.gov Identifier: NCT05227248
• Other Study ID Numbers: FondazioneSanRaffaele
• First Posted: Feb 7, 2022
• Last Update Posted: Feb 23, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 23, 2022