Acute High Fat Bulletproof Coffee vs Black Coffee on Metabolism, Inflammation and Cognitive Function in Healthy Adults

Inflammatory Response Clinical Trial

Official title:

Impact of Bulletproof Coffee on Metabolism, Inflammation and Cognitive Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04307979
• Other study ID #: Bulletproof Coffee
• Secondary ID: H19-02684
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: University of British Columbia
• Contact: Garett S Jackson, B.H.K
• Phone: 1-250-807-9122
• Email: garett11[@]mail.ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function
• Inflammation
• Inflammatory Response
• Leukocytosis
• Triglycerides

Intervention

Dietary Supplement:
• High-fat coffee
A high fat coffee that consists of 29 grams of added fat from grass fed ghee, and MCT oil.
• Black coffee
A regular black coffee with no added caloric content.

Locations

Country	Name	City	State
Canada	University of British Columbia, Okanagan.	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma triglycerides	Circulating triglycerides measured in mmol/L	Change over 3 hours following beverage consumption
Secondary	Cognitive function	Measures of cognitive function including Stroop test, digit substitution, and reaction time measured via computerized test battery.	Change over 3 hours following beverage consumption
Secondary	Immune Cell Activation	Assessment of activation markers on monocytes and neutrophils measured as median fluorescence intensity by flow cytometry.	Change over 3 hours following beverage consumption