The Morning Coffee Study

Appetitive Behavior Clinical Trial

Official title:

The Morning Coffee Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04250740
• Other study ID #: 19-11-008
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior

Intervention

Other:
• Coffee with butter-1
250 mL brewed black coffee with hazelnut flavouring and 50 g water
• Coffee with butter-II
250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-I
• Coffee with butter-III
250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-II

Locations

Country	Name	City	State
Canada	University of Guelph	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gastric emptying	Determined by gastric ultrasound assessment of gastric antrum cross sectional area	0, 30, 60, 90, 120, 150, and 180 minutes
Primary	Please indicate how much you liked or disliked the coffee	Hedonic scale ratings of beverage liking; 9 points from Dislike Extremely to Like Extremely	30-180 minutes
Secondary	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	0 - 180 minutes
Secondary	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	30 - 180 minutes
Secondary	Lunch meal food intake	Weight of food consumed at ad libitum pasta meal	180 minutes