LeukocytosisNCT04307979
Acute High Fat Bulletproof Coffee vs Black Coffee on Metabolism, Inflammation and Cognitive Function in Healthy Adults
A study testing High-fat coffee and Black coffee in people with Leukocytosis and Triglycerides, run by University of British Columbia at 1 site in Canada.
Trial summary
This study will determine whether acute ingestion of a high fat "Bulletproof Coffee" will lead to changes in plasma triglycerides, immune cell function, as well as cognitive function when compared to a black coffee. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Leukocytosis, Triglycerides, Cognitive Function
- What is being tested?
- High-fat coffee and Black coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2020to 31 Dec 2020
- 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
- Must be over the age of 18
- Must drink between 1-4 cups of coffee per day (on average)
- Must be able to tolerate lactose and dairy products
- Have not been sick for the past 3 weeks (immune function)
- Non smoker
- Must be able to fast for 10-12 hours
Who cannot join
- If you are required to take corticosteroids (immune function)
- Cannot understand or speak English
- Individual has an auto-immune disease and requires medication
- Individual is following a ketogenic diet
- Individual has allergy or sensitivity to dairy, coffee or caffeine or coconut oil
- Individual has hypertension
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia, Okanagan.
Kelowna, British Columbia, V1V 1V7
Jonathan P Little, PHD, 1-250-878-6893, jonathan.little@ubc.ca
Garett S Jackson, B.H.K, 1-250 807 9122, garett11@mail.ubc.ca
About this study
Official title: Impact of Bulletproof Coffee on Metabolism, Inflammation and Cognitive Function
This study will determine whether acute ingestion of a high fat "Bulletproof Coffee" will lead to changes in plasma triglycerides, immune cell function, as well as cognitive function when compared to a black coffee.
Read the detailed description
In a randomized crossover design, participants will consume a single bulletproof coffee or a single black coffee separated by ~7 days. Each visit commences in the morning after an overnight fast of 10-12 hours, with no exercise the day prior, no coffee consumption the morning of testing, and completion of a food log for dietary duplication prior to visit 2. A fasting blood draw is obtained and cognitive function tests administered, along with questionnaires to assess gastrointestinal distress, arousal, and hunger/fullness before coffee consumption. Following this, one of the coffee beverages is consumed (randomized to each visit). Cognitive testing and questionnaires are completed at 60 minutes after finishing the coffee, another blood draw at 90 minutes, and then cognitive testing, questionnaires and a final blood draw 180 minutes after consuming the coffee. This procedure is repeated during their second experimental visit, in which they consume the remaining coffee based on their randomization.
- Conditions
- Leukocytosis, Triglycerides, Cognitive Function, Inflammatory Response
- Being tested
- High-fat coffee, Black coffee
- Keywords
- Triglycerides, Leukocyte, Monocyte, Neutrophil, Activation, High-fat
- Medical subject headings
- Leukocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat coffeeDietary supplement
A high fat coffee that consists of 29 grams of added fat from grass fed ghee, and MCT oil.
Black coffeeDietary supplement
A regular black coffee with no added caloric content.
| Study group | Role | What they receive |
|---|---|---|
| Bulletproof Coffee | Experimental | A black coffee (bullet proof coffee keurig pod) with 29 grams of added fat (1 tablespoon bullet proof brain octane medium chain triglyceride oil, and 1 tablespoon bullet proof grass fed ghee) blended for 20 seconds with butter scent that is added to the lid. Receives: Dietary Supplement: High-fat coffee; Dietary Supplement: Black coffee |
| Black Coffee | Placebo comparator | Black coffee that is blended for 20 seconds with butter scent added to the top of the lid. Receives: Dietary Supplement: High-fat coffee; Dietary Supplement: Black coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma triglycerides
Circulating triglycerides measured in mmol/L
Measured: Change over 3 hours following beverage consumption
Secondary outcomes (2)
Cognitive function
Measures of cognitive function including Stroop test, digit substitution, and reaction time measured via computerized test battery.
Measured: Change over 3 hours following beverage consumption
Immune Cell Activation
Assessment of activation markers on monocytes and neutrophils measured as median fluorescence intensity by flow cytometry.
Measured: Change over 3 hours following beverage consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukocytosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Model description
- Randomized double-blind crossover design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
- Investigators
- Jonathan P Little, PhD, Principal investigator, University of British Columbia- Okanagan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307979
- Sponsor's protocol ID
- Bulletproof Coffee
- Other IDs
- H19-02684
- Status last verified
- Mar 2020
- First submitted
- 4 Feb 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data used for publication will be shared in a raw data format. This will include participant ID, and all participant characteristics with no personally identifying information.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bulletproof Coffee on Metabolism, Inflammation and Cognitive Function
- ClinicalTrials.gov ID
- NCT04307979
- Acronym / sponsor ID
- Bulletproof Coffee
- Conditions
- Leukocytosis, Triglycerides, Cognitive Function, Inflammatory Response
- Keywords
- Triglycerides, Leukocyte, Monocyte, Neutrophil, Activation, High-fat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 13 Mar 2020 (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.
This study will determine whether acute ingestion of a high fat "Bulletproof Coffee" will lead to changes in plasma triglycerides, immune cell function, as well as cognitive function when compared to a black coffee.
Detailed description
In a randomized crossover design, participants will consume a single bulletproof coffee or a single black coffee separated by ~7 days. Each visit commences in the morning after an overnight fast of 10-12 hours, with no exercise the day prior, no coffee consumption the morning of testing, and completion of a food log for dietary duplication prior to visit 2. A fasting blood draw is obtained and cognitive function tests administered, along with questionnaires to assess gastrointestinal distress, arousal, and hunger/fullness before coffee consumption. Following this, one of the coffee beverages is consumed (randomized to each visit). Cognitive testing and questionnaires are completed at 60 minutes after finishing the coffee, another blood draw at 90 minutes, and then cognitive testing, questionnaires and a final blood draw 180 minutes after consuming the coffee. This procedure is repeated during their second experimental visit, in which they consume the remaining coffee based on their randomization.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blind crossover design.
| Arm | Type | Receives |
|---|---|---|
| Bulletproof Coffee | Experimental | Dietary Supplement: High-fat coffee, Dietary Supplement: Black coffeeA black coffee (bullet proof coffee keurig pod) with 29 grams of added fat (1 tablespoon bullet proof brain octane medium chain triglyceride oil, and 1 tablespoon bullet proof grass fed ghee) blended for 20 seconds with butter scent that is added to the lid. |
| Black Coffee | Placebo comparator | Dietary Supplement: High-fat coffee, Dietary Supplement: Black coffeeBlack coffee that is blended for 20 seconds with butter scent added to the top of the lid. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Must be over the age of 18
- Must drink between 1-4 cups of coffee per day (on average)
- Must be able to tolerate lactose and dairy products
- Have not been sick for the past 3 weeks (immune function)
- Non smoker
Key exclusion criteria (6 listed)
- If you are required to take corticosteroids (immune function)
- Cannot understand or speak English
- Individual has an auto-immune disease and requires medication
- Individual is following a ketogenic diet
- Individual has allergy or sensitivity to dairy, coffee or caffeine or coconut oil
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 |
|---|---|---|
| High-fat coffeeA high fat coffee that consists of 29 grams of added fat from grass fed ghee, and MCT oil. | Dietary supplement | Black Coffee, Bulletproof Coffee |
| Black coffeeA regular black coffee with no added caloric content. | Dietary supplement | Black Coffee, Bulletproof Coffee |
Primary outcome
Plasma triglycerides
Time frame: Change over 3 hours following beverage consumption
Circulating triglycerides measured in mmol/L
2 secondary outcomes
Cognitive function
Time frame: Change over 3 hours following beverage consumption
Immune Cell Activation
Time frame: Change over 3 hours following beverage consumption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: Yes. Data used for publication will be shared in a raw data format. This will include participant ID, and all participant characteristics with no personally identifying information.
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.
Jonathan P Little, PhD principal investigator
University of British Columbia- Okanagan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fat coffee and Black coffee in people with Leukocytosis and Triglycerides, run by University of British Columbia at 1 site in Canada.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Mar 2020. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Garett S Jackson, B.H.K (1-250-807-9122, garett11@mail.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma triglycerides (time frame: Change over 3 hours following beverage consumption). 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 13 Mar 2020.