Clinical trial NCT04307979: Acute High Fat Bulletproof Coffee vs Black Coffee on Metabolism, Inflammation and Cognitive Function in Healthy Adults
Official title: Impact of Bulletproof Coffee on Metabolism, Inflammation and Cognitive Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leukocytosis
Triglycerides
Cognitive Function
Inflammatory Response
Keywords: Triglycerides
Leukocyte
Monocyte
Neutrophil
Activation
High-fat
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized double-blind crossover design.
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Plasma triglycerides
timeFrame: Change over 3 hours following beverage consumption
Secondary outcomes:
measure: Cognitive function
timeFrame: Change over 3 hours following beverage consumption
measure: Immune Cell Activation
timeFrame: Change over 3 hours following beverage consumption
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia, Okanagan.
state: British Columbia
Study officials:
affiliation: University of British Columbia- Okanagan
name: Jonathan P Little, PhD
role: PRINCIPAL_INVESTIGATOR
References: