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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Response; Cognitive Function; Leukocytosis; Triglycerides
• Intervention / Treatment: Dietary supplement: High-fat coffee; Dietary supplement: 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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Garett S Jackson, B.H.K; Phone Number: 1-250-807-9122; Email: garett11@mail.ubc.ca
• Study Contact Backup: Name: Jonathan P Little, PHD; Phone Number: 1-250-878-6893; Email: jonathan.little@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V 1V7
      • Recruiting
      • University of British Columbia, Okanagan.
      • Contact: Jonathan P Little, PHD; Phone Number: 1-250-878-6893; Email: jonathan.little@ubc.ca
      • Contact: Garett S Jackson, B.H.K; Phone Number: 1-250 807 9122; Email: garett11@mail.ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bulletproof Coffee; 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.	Dietary supplement: High-fat coffee; A high fat coffee that consists of 29 grams of added fat from grass fed ghee, and MCT oil.; Dietary supplement: Black coffee; A regular black coffee with no added caloric content.
Placebo Comparator: Black Coffee; Black coffee that is blended for 20 seconds with butter scent added to the top of the lid.	Dietary supplement: High-fat coffee; A high fat coffee that consists of 29 grams of added fat from grass fed ghee, and MCT oil.; Dietary supplement: Black coffee; A regular black coffee with no added caloric content.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma triglycerides	Circulating triglycerides measured in mmol/L	Change over 3 hours following beverage consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Jonathan P Little, PhD, University of British Columbia- Okanagan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Triglycerides; Leukocyte; Monocyte; Neutrophil; Activation; High-fat
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Leukocyte Disorders; Inflammation; Leukocytosis
• Other Study ID Numbers: Bulletproof Coffee; H19-02684 (Other Identifier: UBC Clinical Research Ethics Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The study protocol and informed consent form will be available immediately upon study publication. The statistical analytical plan will be outlined in detail in the manuscript, however if more details are required, these will be provided. All information will be provided for 36 months following publication of results.
• IPD Sharing Access Criteria: IPD will be provided to credentialed research institutions/university labs. This data may be used for meta-analyses as well as direction for pilot work and future studies. Upon query, it will be determined whether the requesting party is eligible to view the data, both to maintain anonymity of the participants, and to ensure adequate, ethical and responsible use of IPD.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No