Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03326934 |
| Other study ID # |
17-06-002 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 25, 2017 |
| Est. completion date |
August 30, 2018 |
Study information
| Verified date |
April 2019 |
| Source |
University of the Incarnate Word |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Consumption of dark chocolate has been associated with improved blood flow, cardiovascular
function, slowing of degenerative aging processes, as well as enhanced mood and cognitive
performance. Dark chocolate is rich in cocoa flavanols which have both antioxidant effects to
prevent and impede degenerative disease and as well as more immediate effects on local and
cerebral blood flow. One study demonstrated an improvement in contrast sensitivity (CS) which
is the visual ability to detect low contrast targets. Hence dark chocolate may enhance vision
during critical task performance in military and law enforcement settings as well as
every-day tasks such as driving. Whereas it is assumed that visual enhancements from dark
chocolate derive from increased cerebral and/or retinal blood flow, direct measurements are
lacking. Prior research demonstrated that hands free phone communication (verbal distraction)
can delay reaction time and impair CS. Hence in this study our purpose is to determine if
acute consumption of dark chocolate impacts: CS and reaction time with and without verbal
distraction, measures of high and low contrast vision as well as color vision, and bjective
electrophysiological measures of retinal, optic nerve and cortical function. In prior studies
of acute effects of dark chocolate on cognition and CS, the dark chocolate was consumed
90-120 minutes prior to testing. In this study the investigators are using a somewhat larger
dose and beginning electrophysiological testing after consumption with color and CS testing
approximately 1 hour and 30 minutes afterconsumption. The investigators believe this will
capture possible more immediate blood flow changes in retina and cortex based on
electrophysiological measures and CS and cognitive changes later in the session.
A total of 30 subjects will be recruited from UIW and RSO students, staff, faculty and
patients. The age range will be 18 to 65 years and the investigators will attempt to include
comparable numbers of male and female participants. Inclusion criteria include visual acuity
of at least 20/20 in each eye with no evidence of ocular, systemic or neurologic disease or
ocular trauma. Based on prior research using repeated-measures designs, a difference of 0.1
log CS is considered significant and the estimated standard deviation is 0.13 log units.
Hence the effect size = (mean difference)/SD = 0.1/0.13 = 0.76. The estimated minimum number
of subjects to achieve significance at the 5% level with a power of 80%: (1/effect size)2 x
16 = (1/0.76)2 x 16 = 28 subjects.(8,9). Hence 30 subjects will be recruited to account for
subject attrition during the course of the study. Prior to obtaining written informed
consent, each subject will be briefed on the nature of the study by one or more members of
the research team. Subjects will be informed that they will be evaluated with standard vision
tests one hour after consuming a chocolate bar to assess its effects on performance. The dark
chocolate and milk chocolate bars to be used are commercially available from Trader Joe's and
have comparable ingredients and nutrients except for the higher percentage (72%) of cacao
dark chocolate in the experimental bar while the control bar contains 31% milk chocolate
cocao solids which are not associated with acute beneficial effects on performance. As stated
in the informed consent document, subjects will be asked if they have allergies to any of the
ingredients contained in the chocolate bars, and will be excluded from participating if they
answer affirmatively. As noted above, any subjects with ocular, systemic or neurologic
disease, including diabetes and hypoglycemia, will not be allowed to participate in the
study.
A single-blinded crossover design will be used to assess possible effects of the dark or milk
chocolate bars (72% cacao dark chocolate) on visual performance and visual
electrophysiological signals. Double-blinding (experimenter unaware of the type of chocolate)
is not tenable due to the difference in coloration and aroma of the two chocolate bars and
not likely to be a significant source of variability given the objective nature of the visual
performance measures. Subjects will be tested in two one-hour sessions separated by at least
72 hours. Each subject will consume a different chocolate bar one-hour prior to testing with
the order of bars (dark vs. milk chocolate) counter-balanced across subjects. Subjects will
be asked to refrain from consuming coffee or caffeinated drinks on the day of testing and to
consume the bar without milk or milk products which can lessen beneficial effects of dark
chocolate. The subject will be presented the bar in its original wrapper but with the name
masked by tape and she/he will be given a paper plate and napkins and asked to remove and
return the wrapping to the research team member(s). The subject will be offered water during
consumption of the bar which will take place in the research room. Insofar as many of the
subjects will be in-house student volunteers, she/he will then remain in UIWRSO to study,
work-study, finish clinical records, etc. for about 30 minutes. The patient will then undergo
preliminary evaluation to prepare for the testing to commence at least 1 hour after chocolate
bar consumption. This will include measurement of distant visual acuity followed by
refraction to best visual acuity if the patient does not achieve 20/20 in each eye with their
habitual correction. Hence the patient will either wear their habitual correction or lenses
in a trial frame to achieve best vision during testing. The patient will then be prepped for
electro-diagnostic testing including visual-evoked potentials (VEPs) and electro-retinograms
(ERGs) which objectively assess visual cortical and retina/optic nerve function,
respectively. VEPs will be recorded using the Diopsys® system. The subject is seated
comfortably before a reversing checkerboard display. The back of the head, forehead and
temple will be wiped clean using an FDA approved non-abrasive cleaner. High and low contrast
VEPs will be recorded from the back of the head using disposable skin electrodes with
reference and ground electrodes at the forehead and temple, respectively. Cone specific color
VEPs10 will also be recorded using the Diagnosys, LLC system. All VEPs will be recorded
binocularly and not be initiated until one-hour following consumption of the chocolate bar.
The Diopsys® system will be used to record pattern ERGs (optic nerve function), flicker ERGs
(cone function) and the photopic negative response (phNR; cone, bipolar cell and optic nerve
function). Half of the subjects in control and experimental sessions will be tested with ERGs
first and half with VEPs first to control for order effects. These FDA approved
electro-diagnostic tests will be followed by letter chart measures of large and small CS
(Precision Vision, Inc.). Each subject will then be tested with the Innova Systems, Inc.
computer controlled Cone Contrast Test which assesses red, green and blue cone CS as well as
large and small black/white letter CS using an adaptive staircase (like a hearing test) to
determine the lowest visible contrast and overall response time. As described in our previous
study,7 each subject will undergo computer-based CS testing with and without verbal
distraction during testing with order counterbalanced across subjects. The verbal distraction
will be broadcast on a hands-free blue-tooth device to simulate an incoming phone call
consisting of scripted questions to assess memory and cognitive performance while completing
the CS tasks. Following these tests, the subject will be asked to perform a brief (<10
minute) Wii™ shooting game using the Wii™ zapper which is shaped like a small rifle—no
training is necessary. Two-way repeated measures ANOVA will be used to assess CS across
distraction and chocolate bar conditions and post-hoc paired t-tests conducted to identify
specific differences. Within subject ANOVAs and post-hoc t-test comparisons also will be used
to assess amplitude and latency parameters of VEPs and ERGs across dark and milk chocolate
conditions.
