- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04250740
The Morning Coffee Study
November 23, 2023 updated by: Amanda Wright, Ph.D., University of Guelph
The liking of a breakfast meal has been shown to influence food choice throughout the day.
This study will investigate the effects that liking of different coffee beverages has on daily food intake.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a postprandial acute meal crossover blinded study in which 30 fasted young healthy women will consume one of 3 butter-rich coffees, in random order, at each of three study sessions separated by at least 4 days.
Participants will rate the coffee characteristics and complete paper visual analogue scale ratings of alertness, fatigue, nausea, satiety, and comfort for 180 minutes and consume a pasta lunch meal.
A subset of 10 participants will be invited to attend 3 additional study visits where gastric emptying following consumption of each coffee will be assess using gastric ultrasound.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Guelph, Ontario, Canada, N1G 2W1
- Recruiting
- University of Guelph
-
Contact:
- Amanda Wright, PhD
- Phone Number: 54697 5198244120
- Email: ajwright@uoguelph.ca
-
Principal Investigator:
- Amanda Wright, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Generally healthy women
- 20-35 yrs
- BMI of 18.5-26.1 kg/m2 and waist circumference <88cm
- Non-smoking
- Non to moderate alcohol drinkers
- Regular coffee consumers
- Regularly consumes dairy products
- Pre-menopausal with regular monthly periods
- Stable medication use
- Have not gained or lost significant weight during the past 3 months
- Not pregnant or lactating
- Enjoy and be willing to consume pasta with tomato sauce
Exclusion Criteria:
- Any food sensitivity or intolerance
- Any anaphylactic allergy or gastrointestinal disorder
- History of any major disease or medical condition
- Elite or training athletes
- Three Factor Eating Questionnaire restraint score >16
- Taking any natural health products or dietary supplements, other than a multivitamin, that interfere with fat or caffeine digestion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Coffee A
|
250 mL brewed black coffee with hazelnut flavouring and 50 g water
|
Experimental: Coffee B
|
250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-I
|
Experimental: Coffee C
|
250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-II
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Please indicate how much you liked or disliked the coffee
Time Frame: 30-180 minutes
|
Hedonic scale ratings of beverage liking; 9 points from Dislike Extremely to Like Extremely
|
30-180 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Please indicate on the line the creaminess of the coffee
Time Frame: 0 - 180 minutes
|
Visual analogue scale ratings of product attributes; 0-100 mm from Not Creamy at All to Extremely Creamy
|
0 - 180 minutes
|
Please indicate on the line how hungry you are
Time Frame: 30 - 180 minutes
|
Visual analogue scale ratings of product attributes; 0-100 mm from Not Hungry at All to Extremely Hungry
|
30 - 180 minutes
|
Lunch meal food intake
Time Frame: 180 minutes
|
Weight of food consumed at ad libitum pasta meal
|
180 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric emptying
Time Frame: 0, 30, 60, 90, 120, 150, and 180 minutes
|
Determined by gastric ultrasound assessment of gastric antrum cross sectional area
|
0, 30, 60, 90, 120, 150, and 180 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2020
Primary Completion (Estimated)
December 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
January 28, 2020
First Submitted That Met QC Criteria
January 30, 2020
First Posted (Actual)
January 31, 2020
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 23, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 19-11-008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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