Acute High Fat Bulletproof Coffee vs Black Coffee on Metabolism, Inflammation and Cognitive Function in Healthy Adults
Primary Purpose
Leukocytosis, Triglycerides, Cognitive Function
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-fat coffee
Black coffee
Sponsored by
About this trial
This is an interventional basic science trial for Leukocytosis focused on measuring Triglycerides, Leukocyte, Monocyte, Neutrophil, Activation, High-fat
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
Sites / Locations
- University of British Columbia, Okanagan.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bulletproof Coffee
Black Coffee
Arm Description
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.
Black coffee that is blended for 20 seconds with butter scent added to the top of the lid.
Outcomes
Primary Outcome Measures
Plasma triglycerides
Circulating triglycerides measured in mmol/L
Secondary Outcome Measures
Cognitive function
Measures of cognitive function including Stroop test, digit substitution, and reaction time measured via computerized test battery.
Immune Cell Activation
Assessment of activation markers on monocytes and neutrophils measured as median fluorescence intensity by flow cytometry.
Full Information
NCT ID
NCT04307979
First Posted
February 4, 2020
Last Updated
March 11, 2020
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT04307979
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukocytosis, Triglycerides, Cognitive Function, Inflammatory Response
Keywords
Triglycerides, Leukocyte, Monocyte, Neutrophil, Activation, High-fat
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized double-blind crossover design.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bulletproof Coffee
Arm Type
Experimental
Arm Description
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.
Arm Title
Black Coffee
Arm Type
Placebo Comparator
Arm Description
Black coffee that is blended for 20 seconds with butter scent added to the top of the lid.
Intervention Type
Dietary Supplement
Intervention Name(s)
High-fat coffee
Intervention Description
A high fat coffee that consists of 29 grams of added fat from grass fed ghee, and MCT oil.
Intervention Type
Dietary Supplement
Intervention Name(s)
Black coffee
Intervention Description
A regular black coffee with no added caloric content.
Primary Outcome Measure Information:
Title
Plasma triglycerides
Description
Circulating triglycerides measured in mmol/L
Time Frame
Change over 3 hours following beverage consumption
Secondary Outcome Measure Information:
Title
Cognitive function
Description
Measures of cognitive function including Stroop test, digit substitution, and reaction time measured via computerized test battery.
Time Frame
Change over 3 hours following beverage consumption
Title
Immune Cell Activation
Description
Assessment of activation markers on monocytes and neutrophils measured as median fluorescence intensity by flow cytometry.
Time Frame
Change over 3 hours following beverage consumption
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Garett S Jackson, B.H.K
Phone
1-250-807-9122
Email
garett11@mail.ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan P Little, PhD
Phone
1-250-878-6893
Email
jonathan.little@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan P Little, PhD
Organizational Affiliation
University of British Columbia- Okanagan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia, Okanagan.
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 1V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan P Little, PHD
Phone
1-250-878-6893
Email
jonathan.little@ubc.ca
First Name & Middle Initial & Last Name & Degree
Garett S Jackson, B.H.K
Phone
1-250 807 9122
Email
garett11@mail.ubc.ca
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Acute High Fat Bulletproof Coffee vs Black Coffee on Metabolism, Inflammation and Cognitive Function in Healthy Adults
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