The Morning Coffee Study

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
The Morning Coffee Study

Conditions
-----------------
Appetitive Behavior

Intervention / Treatment
-----------------
* Other: Coffee with butter-1
* Other: Coffee with butter-II
* Other: Coffee with butter-III


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coffee A<br> | Other: Coffee with butter-1<br>* 250 mL brewed black coffee with hazelnut flavouring and 50 g water<br>|
| Experimental: Coffee B<br> | Other: Coffee with butter-II<br>* 250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-I<br>|
| Experimental: Coffee C<br> | Other: Coffee with butter-III<br>* 250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-II<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Lunch meal food intake | Weight of food consumed at ad libitum pasta meal | 180 minutes |