Dietary SupplementationNCT03326934
Impact of Dark Chocolate on Visual Performance
A study testing Dark chocolate and Milk Chocolate in people with Dietary Supplementation, run by University of the Incarnate Word at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplementation
- What is being tested?
- Dark chocolate and Milk Chocolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2017to 30 Aug 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of the Incarnate Word Rosenberg School of Optometry
San Antonio, Texas, 78229
About this study
Official title: The Impact of Chocolate on Visual Performance: Psychophysics and Electrophysiology
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.
Read the detailed 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.
- Conditions
- Dietary Supplementation
- 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
Trader Joe's 72% Cacao Dark Chocolate bar, 47g, 34g cacao, total flavanols: 316.3 mg.
Milk ChocolateDietary supplement
Trader Joe's Crispy Rice Milk Chocolate bar: 40g, 12.4g milk chocolate cocoa; total flavanols: 40 mg.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Dark chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20 minutes per session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start25 Jun 2017
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary SupplementationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Incarnate Word
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff C Rabin, OD, MS, PhD, Principal investigator, University of the Incarnate Word
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326934
- Sponsor's protocol ID
- 17-06-002
- Status last verified
- Apr 2019
- First submitted
- 19 Oct 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29710322
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Chocolate on Visual Performance: Psychophysics and Electrophysiology
- ClinicalTrials.gov ID
- NCT03326934
- Acronym / sponsor ID
- 17-06-002
- Conditions
- Dietary Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of the Incarnate WordUniversity, hospital or other
- Study start
- 25 Jun 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 31 Oct 2017 (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 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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Milk Chocolate | Sham comparator | Dietary Supplement: Milk ChocolateEach subject consumes a Trader Joe's Crispy Rice Milk Chocolate bar: 40g, 12.4g milk chocolate cocoa; total flavanols: 40 mg. |
| Dark Chocolate | Experimental | Dietary Supplement: Dark chocolateEach subject consumes a Trader Joe's 72% Cacao Dark Chocolate bar: 47g, 34g cacao, total flavanols: 316.3 mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 chocolateTrader Joe's 72% Cacao Dark Chocolate bar, 47g, 34g cacao, total flavanols: 316.3 mg. | Dietary supplement | Dark Chocolate |
| Milk ChocolateTrader Joe's Crispy Rice Milk Chocolate bar: 40g, 12.4g milk chocolate cocoa; total flavanols: 40 mg. | Dietary supplement | Milk Chocolate |
Primary outcome
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.
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.
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.
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.
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 18 Apr 2019.
- Derived from this study: 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.
- 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.
Jeff C Rabin, OD, MS, PhD principal investigator
University of the Incarnate Word
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 Dietary Supplementation, run by University of the Incarnate Word at 1 site in United States.
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 5 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 18 Apr 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Visual acuity, contrast sensitivity and color vision. (time frame: 20 minutes per session). The study lists 4 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 NCT03326934, which also lists 1 linked publication.
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 18 Apr 2019.