CaffeineNCT02080845
Effects of a Cocoa Shot on the Human Brain 2
A study testing no caffeine, high caffeine and no theobromine in people with Caffeine, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The Hershey Company is interested in investigating the effects of various chocolate beverages on brain physiology and cognitive function. The main substances in the drinks that are known to influence the brain are caffeine and related chemicals such as theobromine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Caffeine
- What is being tested?
- no caffeine, high caffeine and no theobromine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Consume 200-500 mg caffeine daily
- Willing and capable of signing the informed consent
- Willing to attend 4 testing sessions that will take 4-6 hours each AND will be at least 10 days apart
- Willing to abstain from caffeine for 16 hours before each testing session
- Willing to and able to have MRIs
Who cannot join
- As determined from the medical screening session
- active neurological dysfunction (such as a major Axis I psychopathology, Alzheimer's disease, Parkinson's disease, prior history of stroke, epilepsy, or serious central nervous system (CNS) trauma)
- attention deficit hyperactivity disorder (ADHD)
- migraines
- hypertension
- diabetes
Show all 13Show fewer
- peripheral vascular disease
- taking vasoactive medications (such as anti-hypertensive medications)
- depression that has not been on a stable medical treatment for at least 4 weeks
- Pregnancy
- Allergy to chocolate, peanuts, tree nuts, egg, soy, milk, wheat
- Color blindness
- Individuals who are or potentially may be cognitively or psychologically impaired, or who otherwise have a limited capacity to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The Hershey Company is interested in investigating the effects of various chocolate beverages on brain physiology and cognitive function. The main substances in the drinks that are known to influence the brain are caffeine and related chemicals such as theobromine. Caffeine and chemicals related to caffeine are all naturally occurring and all potentially alter brain physiology. This study will evaluate changes in brain blood flow and cognition following the consumption of drinks with various combinations of the Primary Ingredients. The study proposed here will evaluate ingredients in a 4-arm cross-over double-blind design in an attempt to understand the differential effects of these compounds in chocolate drinks.
- Conditions
- Caffeine
- Being tested
- no caffeine, high caffeine, no theobromine, low theobromine, high theobromine
- Keywords
- Caffeine, MRI, Brain blood flow, Cognition, Perfusion, Resting functional magnetic resonance imaging (fMRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no caffeineDietary supplement
high caffeineDietary supplement
no theobromineDietary supplement
low theobromineDietary supplement
high theobromineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| no caffeine & no theobromine | Placebo comparator | Drink 1 Receives: Dietary Supplement: no caffeine; Dietary Supplement: no theobromine |
| no caffeine & low theobromine | Experimental | Drink 2 Receives: Dietary Supplement: no caffeine; Dietary Supplement: low theobromine |
| no caffeine & high theobromine | Experimental | Drink 3 Receives: Dietary Supplement: no caffeine; Dietary Supplement: high theobromine |
| high caffeine & no theobromine | Experimental | Drink 4 Receives: Dietary Supplement: high caffeine; Dietary Supplement: no theobromine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Working Memory (% correct)
N-Back Task
Measured: Baseline, 1.5 hour and 3.5 hours post beverage
Change in Response Time (milliseconds)
Choice ResponseTime Task
Measured: Baseline, 1.5 hour and 3.5 hours post beverage
Change in Short Term Memory (# correct)
Hopkins Verbal Learning Task (HVLT)
Measured: Baseline, 1.5 hour and 3.5 hours post beverage
Change in Mood (change in Likert scale score)
Profile of Mood Status (POMS)
Measured: Baseline, 1.5 hour and 3.5 hours post beverage
Change in Attention (% accuracy)
Eriksen Flanker Task
Measured: Baseline, 1.5 hour and 3.5 hours post beverage
Change in Executive Function (# correct)
Stroop Task
Measured: Baseline, 1.5 hour and 3.5 hours post beverage
Secondary outcomes (4)
Change in Brain Blood Flow (ml/g/min)
Non-invasive brain perfusion measured with arterial spin labeling magnetic resonance imaging
Measured: 1 hour post beverage
% Change in Heart Rate (beats/minute)
Pulse
Measured: before, 1 hour, and 3 hour post beverage
% Change in Blood Pressure (mm Hg)
Measured: before, 1 hour, and 3 hour post beverage
Change in Respiration (breaths/minute)
Measured: before, 1 hour, and 3 hour post beverage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaffeineStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Hershey Company
- Responsible party
- Sponsor
- Investigators
- Paul J Laurient, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080845
- Sponsor's protocol ID
- IRB00026868
- Status last verified
- Jul 2018
- First submitted
- 4 Mar 2014
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Cocoa Shot on the Human Brain 2
- ClinicalTrials.gov ID
- NCT02080845
- Acronym / sponsor ID
- IRB00026868
- Conditions
- Caffeine
- Keywords
- Caffeine, MRI, Brain blood flow, Cognition, Perfusion, Resting functional magnetic resonance imaging (fMRI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- The Hershey Company
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Mar 2014 (estimated)
- 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 Hershey Company is interested in investigating the effects of various chocolate beverages on brain physiology and cognitive function. The main substances in the drinks that are known to influence the brain are caffeine and related chemicals such as theobromine. Caffeine and chemicals related to caffeine are all naturally occurring and all potentially alter brain physiology. This study will evaluate changes in brain blood flow and cognition following the consumption of drinks with various combinations of the Primary Ingredients. The study proposed here will evaluate ingredients in a 4-arm cross-over double-blind design in an attempt to understand the differential effects of these compounds in chocolate drinks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| no caffeine & no theobromine | Placebo comparator | Dietary Supplement: no caffeine, Dietary Supplement: no theobromineDrink 1 |
| no caffeine & low theobromine | Experimental | Dietary Supplement: no caffeine, Dietary Supplement: low theobromineDrink 2 |
| no caffeine & high theobromine | Experimental | Dietary Supplement: no caffeine, Dietary Supplement: high theobromineDrink 3 |
| high caffeine & no theobromine | Experimental | Dietary Supplement: high caffeine, Dietary Supplement: no theobromineDrink 4 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Consume 200-500 mg caffeine daily
- Willing and capable of signing the informed consent
- Willing to attend 4 testing sessions that will take 4-6 hours each AND will be at least 10 days apart
- Willing to abstain from caffeine for 16 hours before each testing session
- Willing to and able to have MRIs
Key exclusion criteria (13 listed)
- As determined from the medical screening session
- Color blindness
- Individuals who are or potentially may be cognitively or psychologically impaired, or who otherwise have a limited capacity to provide consent
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 |
|---|---|---|
| no caffeine | Dietary supplement | no caffeine & high theobromine, no caffeine & low theobromine, no caffeine & no theobromine |
| high caffeine | Dietary supplement | high caffeine & no theobromine |
| no theobromine | Dietary supplement | high caffeine & no theobromine, no caffeine & no theobromine |
| low theobromine | Dietary supplement | no caffeine & low theobromine |
| high theobromine | Dietary supplement | no caffeine & high theobromine |
Primary outcome
Change in Working Memory (% correct)
Time frame: Baseline, 1.5 hour and 3.5 hours post beverage
N-Back Task
Change in Response Time (milliseconds)
Time frame: Baseline, 1.5 hour and 3.5 hours post beverage
Choice ResponseTime Task
Change in Short Term Memory (# correct)
Time frame: Baseline, 1.5 hour and 3.5 hours post beverage
Hopkins Verbal Learning Task (HVLT)
Change in Mood (change in Likert scale score)
Time frame: Baseline, 1.5 hour and 3.5 hours post beverage
Profile of Mood Status (POMS)
Change in Attention (% accuracy)
Time frame: Baseline, 1.5 hour and 3.5 hours post beverage
Eriksen Flanker Task
Change in Executive Function (# correct)
Time frame: Baseline, 1.5 hour and 3.5 hours post beverage
Stroop Task
4 secondary outcomes
Change in Brain Blood Flow (ml/g/min)
Time frame: 1 hour post beverage
% Change in Heart Rate (beats/minute)
Time frame: before, 1 hour, and 3 hour post beverage
% Change in Blood Pressure (mm Hg)
Time frame: before, 1 hour, and 3 hour post beverage
Change in Respiration (breaths/minute)
Time frame: before, 1 hour, and 3 hour post beverage
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 Jul 2018.
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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.
Paul J Laurient, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing no caffeine, high caffeine and no theobromine in people with Caffeine, run by Wake Forest University Health Sciences 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 13 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 Jul 2018. 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?
Change in Working Memory (% correct) (time frame: Baseline, 1.5 hour and 3.5 hours post beverage). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2018.