NCT04307979

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

February 4, 2020

Last Update Submit

March 11, 2020

Conditions

LeukocytosisTriglyceridesCognitive FunctionInflammatory Response

Keywords

TriglyceridesLeukocyteMonocyteNeutrophilActivationHigh-fat

Outcome Measures

Primary Outcomes (1)

  • Plasma triglycerides

    Circulating triglycerides measured in mmol/L

    Change over 3 hours following beverage consumption

Secondary Outcomes (2)

  • Cognitive function

    Change over 3 hours following beverage consumption

  • Immune Cell Activation

    Change over 3 hours following beverage consumption

Study Arms (2)

Bulletproof Coffee

EXPERIMENTAL

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 coffeeDietary Supplement: Black coffee

Black Coffee

PLACEBO COMPARATOR

Black coffee that is blended for 20 seconds with butter scent added to the top of the lid.

Dietary Supplement: High-fat coffeeDietary Supplement: Black coffee

Interventions

High-fat coffeeDIETARY_SUPPLEMENT

A high fat coffee that consists of 29 grams of added fat from grass fed ghee, and MCT oil.

Black CoffeeBulletproof Coffee
Black coffeeDIETARY_SUPPLEMENT

A regular black coffee with no added caloric content.

Black CoffeeBulletproof Coffee

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

RECRUITING

MeSH Terms

Conditions

Leukocytosis

Condition Hierarchy (Ancestors)

Leukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jonathan P Little, PhD

    University of British Columbia- Okanagan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Garett S Jackson, B.H.K

CONTACT

1-250-807-9122garett11@mail.ubc.ca

Jonathan P Little, PhD

CONTACT

1-250-878-6893jonathan.little@ubc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized double-blind crossover design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 4, 2020

First Posted

March 13, 2020

Study Start

January 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations

CA(1)