Retinal VascularNCT05227248
Chocolate Dynamic Vessel Analysis
A study testing Dark chocolate and Milk Chocolate in people with Retinal Vascular, run by Querques Giuseppe at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Vascular
- What is being tested?
- Dark chocolate and Milk Chocolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 9 Apr 2021to 13 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18 years or older
- Healthy volunteers
- No vascular diseases
- No ocular diseases
- Volunteers capable of understanding informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Retinal Vascular
- Being tested
- Dark chocolate, Milk Chocolate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dark chocolateDietary supplement
Patients were administered 20 grams of dark chocolate
Milk ChocolateDietary supplement
Patients were administered 7.5 grams of milk chocolate
| Study group | Role | What they receive |
|---|---|---|
| Main study arm | Experimental | Patients received intervention 1 and then intervention 2 after 7 weeks Receives: Dietary Supplement: Dark chocolate; Dietary Supplement: Milk Chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal perfusion
Changes in retinal perfusion using Optical Coherence Tomography Angiography
Measured: Baseline, 2 hours after intervention
Retinal vascular response
Changes in retinal vascular response to flicker stimulation using Dynamic Vessels Analysis and Retinal Vessels Analysis
Measured: Baseline, 2 hours after intervention
Secondary outcomes (1)
Visual Acuity
Best Corrected Visual Acuity changes
Measured: Baseline, 2 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start9 Apr 2021
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Retinal VascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Querques Giuseppe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Querques Giuseppe, Ospedale San Raffaele
- Investigators
- Francesco Bandello, MD, Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227248
- Sponsor's protocol ID
- FondazioneSanRaffaele
- Status last verified
- Mar 2025
- First submitted
- 26 Jan 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27847598Huang 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.
PubMed 25230403McClintic 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.
PubMed 26135638Siedlecki 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.
PubMed 31556937Rabin 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.
PubMed 29710322Sacconi 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.
PubMed 39215063
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Chocolate on Anatomy and Functionality of Retinal Blood Vessels
- ClinicalTrials.gov ID
- NCT05227248
- Acronym / sponsor ID
- FondazioneSanRaffaele
- Conditions
- Retinal Vascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Querques GiuseppeUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main study arm | Experimental | Dietary Supplement: Dark chocolate, Dietary Supplement: Milk ChocolatePatients received intervention 1 and then intervention 2 after 7 weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 18 years or older
- Healthy volunteers
- No vascular diseases
- No ocular diseases
- Volunteers capable of understanding informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dark chocolatePatients were administered 20 grams of dark chocolate | Dietary supplement | Main study arm |
| Milk ChocolatePatients were administered 7.5 grams of milk chocolate | Dietary supplement | Main study arm |
Primary outcome
Retinal perfusion
Time frame: Baseline, 2 hours after intervention
Changes in retinal perfusion using Optical Coherence Tomography Angiography
Retinal vascular response
Time frame: Baseline, 2 hours after intervention
Changes in retinal vascular response to flicker stimulation using Dynamic Vessels Analysis and Retinal Vessels Analysis
1 secondary outcome
Visual Acuity
Time frame: Baseline, 2 hours after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 27847598de 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.
- Background: PubMed 25230403Huang 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.
- Background: PubMed 26135638McClintic 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.
- Background: PubMed 31556937Siedlecki 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.
- Background: PubMed 29710322Rabin 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.
- Derived from this study: PubMed 39215063Sacconi 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.
- Nutrition Foundation of ItalyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Bandello, MD principal investigator
Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dark chocolate and Milk Chocolate in people with Retinal Vascular, run by Querques Giuseppe at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal perfusion (time frame: Baseline, 2 hours after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05227248, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.