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

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ClinicalTrials.gov Identifier: NCT04307979
Recruitment Status : Unknown
Verified March 2020 by Jonathan Little, University of British Columbia.
Recruitment status was:  Recruiting
First Posted : March 13, 2020
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Leukocytosis Triglycerides Cognitive Function Inflammatory Response Dietary Supplement: High-fat coffee Dietary Supplement: Black coffee Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized double-blind crossover design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of Bulletproof Coffee on Metabolism, Inflammation and Cognitive Function
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Plasma triglycerides [ Time Frame: Change over 3 hours following beverage consumption ]
    Circulating triglycerides measured in mmol/L


Secondary Outcome Measures :
  1. Cognitive function [ Time Frame: Change over 3 hours following beverage consumption ]
    Measures of cognitive function including Stroop test, digit substitution, and reaction time measured via computerized test battery.

  2. Immune Cell Activation [ Time Frame: Change over 3 hours following beverage consumption ]
    Assessment of activation markers on monocytes and neutrophils measured as median fluorescence intensity by flow cytometry.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04307979


Contacts
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Contact: Garett S Jackson, B.H.K 1-250-807-9122 garett11@mail.ubc.ca
Contact: Jonathan P Little, PhD 1-250-878-6893 jonathan.little@ubc.ca

Locations
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Canada, British Columbia
University of British Columbia, Okanagan. Recruiting
Kelowna, British Columbia, Canada, V1V 1V7
Contact: Jonathan P Little, PHD    1-250-878-6893    jonathan.little@ubc.ca   
Contact: Garett S Jackson, B.H.K    1-250 807 9122    garett11@mail.ubc.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Jonathan P Little, PhD University of British Columbia- Okanagan
More Information
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Responsible Party: Jonathan Little, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04307979    
Other Study ID Numbers: Bulletproof Coffee
H19-02684 ( Other Identifier: UBC Clinical Research Ethics Board )
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Little, University of British Columbia:
Triglycerides
Leukocyte
Monocyte
 Neutrophil
Activation
High-fat
Additional relevant MeSH terms:
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Leukocytosis
Inflammation
Pathologic Processes
Leukocyte Disorders
Hematologic Diseases