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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04307979
Other study ID # Bulletproof Coffee
Secondary ID H19-02684
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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