Impact of Dark Chocolate on Visual Performance

NCT03326934 | Completed

• 1 other identifier: 17-06-002
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to conduct a randomized, single-masked crossover study to determine if acute consumption of a commercially available, highly palatable dark chocolate bar can improve visual performance. Vision testing will include multiple measures of contrast and color perception, reaction time, effects of distraction on visual performance during simulated hands-free phone calls, simulated marksmanship, as well as multiple, objective electro-diagnostic tests including standard and color visual-evoked potentials and various types of electro-retinograms to assess visual pathway function.

Conditions

Dietary Supplementation

Outcome Measures

Primary Outcomes (4)

• Visual acuity, contrast sensitivity and color vision.

  High and low contrast visual acuity, contrast sensitivity and color vision will be assessed using letter charts and computer generated stimuli. Thresholds will be compared using within subject repeated measures ANOVA and post-hoc paired t-tests across Dark and Milk chocolate. Z-scores may be used to combine data with different dependent variables.

  20 minutes per session

• Effects of distraction on visual performance during simulated hands-free phone calls.

  Measures of color vision contrast sensitivity and low contrast visual acuity will be measured with and without a simulated hands-free phone call. will be compared using within subject repeated measures ANOVA and post-hoc paired t-tests across Dark and Milk chocolate. Z-scores may be used to combine data with different dependent variables.

  20 minutes per session.

• Visual-electrodiagnostic testing.

  The amplitude and latency of visual brain-waves (VEPs) and eye-waves (ERGs) will be compared using within subject repeated measures ANOVA and post-hoc paired t-tests across Dark and Milk chocolate. Z-scores may be used to combine data with different dependent variables.

  60 minutes per session

• Simulated marksmanship.

  A Nintendo Wii shooting game will be used to obtain accuracy scores and time for completion. Data will be expressed as throughput: ration of accuracy/time for completion. Throughput will be compared using within subject repeated measures ANOVA and post-hoc paired t-tests across Dark and Milk chocolate.

  20 minutes per session

Study Arms (2)

Milk Chocolate

SHAM COMPARATOR

Each subject consumes a Trader Joe's Crispy Rice Milk Chocolate bar: 40g, 12.4g milk chocolate cocoa; total flavanols: 40 mg.

Dietary Supplement: Milk Chocolate

Dark Chocolate

EXPERIMENTAL

Each subject consumes a Trader Joe's 72% Cacao Dark Chocolate bar: 47g, 34g cacao, total flavanols: 316.3 mg.

Dietary Supplement: Dark chocolate

Interventions

Dark chocolate DIETARY_SUPPLEMENT

Trader Joe's 72% Cacao Dark Chocolate bar, 47g, 34g cacao, total flavanols: 316.3 mg.

Dark Chocolate

Milk Chocolate DIETARY_SUPPLEMENT

Trader Joe's Crispy Rice Milk Chocolate bar: 40g, 12.4g milk chocolate cocoa; total flavanols: 40 mg.

Milk Chocolate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Visual acuity of at least 20/20 in each eye
• Absence of ocular disease
• Absence of ocular trauma
• Absence of systemic disease
• Absence of neurologic disease

You may not qualify if:

• Visual acuity less than 20/20 in either eye
• Presence of ocular disease
• Presence or history of ocular trauma
• Presence of systemic disease
• Presence of neurologic disease

Sponsors & Collaborators

• University of the Incarnate Word: lead

Study Sites (1)

University of the Incarnate Word Rosenberg School of Optometry

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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: 29710322 DERIVED

Study Officials

• Jeff C Rabin, OD, MS, PhD

  University of the Incarnate Word

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: None of the subjects will be aware of the intent of the study to the type of chocolate consumed prior to each of two testing sessions
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, single-masked crossover study to assess potential effects of dark chocolate vs. milk chocolate on multiple aspects of visual function and performance.

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 31, 2017
• Study Start: June 25, 2017
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)