NCT05227248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

January 26, 2022

Last Update Submit

March 11, 2025

Conditions

Retinal Vascular

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Visual Acuity

    Baseline, 2 hours after intervention

Study Arms (1)

Main study arm

EXPERIMENTAL

Patients received intervention 1 and then intervention 2 after 7 weeks

Dietary Supplement: Dark chocolateDietary Supplement: Milk Chocolate

Interventions

Dark chocolateDIETARY_SUPPLEMENT

Patients were administered 20 grams of dark chocolate

Main study arm
Milk ChocolateDIETARY_SUPPLEMENT

Patients were administered 7.5 grams of milk chocolate

Main study arm

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giuseppe Querques

Milan, 20134, Italy

Location

Related Publications (6)

  • 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.

    PMID: 27847598BACKGROUND

  • 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.

    PMID: 25230403BACKGROUND

  • 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.

    PMID: 26135638BACKGROUND

  • 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.

    PMID: 31556937BACKGROUND

  • 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.

    PMID: 29710322BACKGROUND

  • Sacconi R, Pezzella M, Ribarich N, Menean M, Servillo A, Bandello F, Querques G. Benefits of dark chocolate intake on retinal vessels functionality: a randomized, blind, crossover clinical trial. Sci Rep. 2024 Aug 30;14(1):20203. doi: 10.1038/s41598-024-70289-7.

    PMID: 39215063DERIVED

Related Links

Study Officials

  • Francesco Bandello, MD

    Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 7, 2022

Study Start

April 9, 2021

Primary Completion

July 13, 2021

Study Completion

July 13, 2021

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)