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Impact of Dark Chocolate on Visual Performance

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ClinicalTrials.gov Identifier: NCT03326934
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
University of the Incarnate Word

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.

Condition or disease Intervention/treatment Phase
Dietary Supplementation Dietary Supplement: Dark chocolate Dietary Supplement: Milk Chocolate Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, single-masked crossover study to assess potential effects of dark chocolate vs. milk chocolate on multiple aspects of visual function and performance.
Masking: Single (Participant)
Masking Description: 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
Primary Purpose: Basic Science
Official Title: The Impact of Chocolate on Visual Performance: Psychophysics and Electrophysiology
Actual Study Start Date : June 25, 2017
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : June 20, 2019

Arm Intervention/treatment
Sham Comparator: Milk Chocolate
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
Trader Joe's Crispy Rice Milk Chocolate bar: 40g, 12.4g milk chocolate cocoa; total flavanols: 40 mg.

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




Primary Outcome Measures :
  1. Visual acuity, contrast sensitivity and color vision. [ Time Frame: 20 minutes per session ]
    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.

  2. Effects of distraction on visual performance during simulated hands-free phone calls. [ Time Frame: 20 minutes per session. ]
    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.

  3. Visual-electrodiagnostic testing. [ Time Frame: 60 minutes per session ]
    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.

  4. Simulated marksmanship. [ Time Frame: 20 minutes per session ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326934


Contacts
Contact: Jeff C Rabin, OD, MS, PhD 210-842-8653 rabin@uiwtx.edu

Locations
United States, Texas
University of the Incarnate Word Rosenberg School of Optometry Recruiting
San Antonio, Texas, United States, 78229
Contact: Jeff C Rabin, OD, MS, PhD    210-842-8653    rabin@uiwtx.edu   
Sponsors and Collaborators
University of the Incarnate Word
Investigators
Principal Investigator: Jeff C Rabin, OD, MS, PhD University of the Incarnate Word
  Study Documents (Full-Text)

Documents provided by University of the Incarnate Word:
Informed Consent Form  [PDF] June 20, 2018
Study Protocol  [PDF] June 20, 2018


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of the Incarnate Word
ClinicalTrials.gov Identifier: NCT03326934     History of Changes
Other Study ID Numbers: 17-06-002
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No