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The Morning Coffee Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250740
Recruitment Status : Suspended (Due to COVID-19 this research needed to pause in March 2020. We plan to start the study again when we have approval to do so.)
First Posted : January 31, 2020
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Amanda Wright, Ph.D., University of Guelph

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.

Condition or disease Intervention/treatment Phase
Appetitive Behavior Other: Coffee with water Other: Coffee with butter-I Other: Coffee with butter-II Not Applicable

Detailed Description:
This is a postprandial acute meal crossover blinded study in which 30 fasted young healthy women will consume one of two butter-rich coffees, or black coffee, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Morning Coffee Study
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Coffee A Other: Coffee with water
250 mL brewed black coffee with hazelnut flavouring and 50 g water

Experimental: Coffee B Other: Coffee with butter-I
250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-I

Experimental: Coffee C Other: Coffee with butter-II
250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-II




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Lunch meal food intake [ Time Frame: 180 minutes ]
    Weight of food consumed at ad libitum pasta meal



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   We aim to recruit adults with regular menstrual periods, whereby we would include an eligible menstruating participant who identifies as a gender other than female.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250740


Locations
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Canada, Ontario
University of Guelph
Guelph, Ontario, Canada, N1G 2W1
Sponsors and Collaborators
University of Guelph
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Responsible Party: Amanda Wright, Ph.D., Associate Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT04250740    
Other Study ID Numbers: 19-11-008
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No