Appetitive BehaviorNCT04250740
The Morning Coffee Study
A study testing Coffee with butter-1, Coffee with butter-II and Coffee with butter-III in people with Appetitive Behavior, run by University of Guelph at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Coffee with butter-1, Coffee with butter-II and Coffee with butter-III
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2020to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Appetitive Behavior
- Being tested
- Coffee with butter-1, Coffee with butter-II, Coffee with butter-III
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coffee with butter-1Other
250 mL brewed black coffee with hazelnut flavouring and 50 g water
Coffee with butter-IIOther
250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-I
Coffee with butter-IIIOther
250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-II
| Study group | Role | What they receive |
|---|---|---|
| Coffee A | Experimental | Not described Receives: Other: Coffee with butter-1 |
| Coffee B | Experimental | Not described Receives: Other: Coffee with butter-II |
| Coffee C | Experimental | Not described Receives: Other: Coffee with butter-III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Please indicate how much you liked or disliked the coffee
Hedonic scale ratings of beverage liking; 9 points from Dislike Extremely to Like Extremely
Measured: 30-180 minutes
Secondary outcomes (3)
Please indicate on the line the creaminess of the coffee
Visual analogue scale ratings of product attributes; 0-100 mm from Not Creamy at All to Extremely Creamy
Measured: 0 - 180 minutes
Please indicate on the line how hungry you are
Visual analogue scale ratings of product attributes; 0-100 mm from Not Hungry at All to Extremely Hungry
Measured: 30 - 180 minutes
Lunch meal food intake
Weight of food consumed at ad libitum pasta meal
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start30 Jan 2020
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Wright, Ph.D., University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250740
- Sponsor's protocol ID
- 19-11-008
- Status last verified
- Dec 2024
- First submitted
- 28 Jan 2020
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Morning Coffee Study
- ClinicalTrials.gov ID
- NCT04250740
- Acronym / sponsor ID
- 19-11-008
- Conditions
- Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coffee A | Experimental | Other: Coffee with butter-1 |
| Coffee B | Experimental | Other: Coffee with butter-II |
| Coffee C | Experimental | Other: Coffee with butter-III |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coffee with butter-1250 mL brewed black coffee with hazelnut flavouring and 50 g water | Other | Coffee A |
| Coffee with butter-II250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-I | Other | Coffee B |
| Coffee with butter-III250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-II | Other | Coffee C |
Primary outcome
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
3 secondary outcomes
Please indicate on the line the creaminess of the coffee
Time frame: 0 - 180 minutes
Please indicate on the line how hungry you are
Time frame: 30 - 180 minutes
Lunch meal food intake
Time frame: 180 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee with butter-1, Coffee with butter-II and Coffee with butter-III in people with Appetitive Behavior, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Please indicate how much you liked or disliked the coffee (time frame: 30-180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.