Chocolate Dynamic Vessel Analysis

NCT ID: NCT05227248

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-09

Study Completion Date

2021-07-13

Brief Summary

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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.

Detailed Description

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Conditions

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Retinal Vascular

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Main study arm

Patients received intervention 1 and then intervention 2 after 7 weeks

Group Type EXPERIMENTAL

Dark chocolate

Intervention Type DIETARY_SUPPLEMENT

Patients were administered 20 grams of dark chocolate

Milk Chocolate

Intervention Type DIETARY_SUPPLEMENT

Patients were administered 7.5 grams of milk chocolate

Interventions

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Dark chocolate

Patients were administered 20 grams of dark chocolate

Intervention Type DIETARY_SUPPLEMENT

Milk Chocolate

Patients were administered 7.5 grams of milk chocolate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Querques Giuseppe

OTHER

Sponsor Role lead

Responsible Party

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Querques Giuseppe

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Francesco Bandello, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Raffaele

Locations

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Giuseppe Querques

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 27847598 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25230403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26135638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31556937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29710322 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39215063 (View on PubMed)

Related Links

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https://www.nutrition-foundation.it/

Nutrition Foundation of Italy

Other Identifiers

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FondazioneSanRaffaele

Identifier Type: -

Identifier Source: org_study_id

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