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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

Tracking Information
First Submitted Date  ICMJE January 28, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date October 28, 2020
Actual Study Start Date  ICMJE January 30, 2020
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • 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
  • 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
  • Lunch meal food intake [ Time Frame: 180 minutes ]
    Weight of food consumed at ad libitum pasta meal
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Morning Coffee Study
Official Title  ICMJE The Morning Coffee Study
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Appetitive Behavior
Intervention  ICMJE
  • Other: Coffee with water
    250 mL brewed black coffee with hazelnut flavouring and 50 g water
  • Other: Coffee with butter-I
    250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-I
  • Other: Coffee with butter-II
    250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-II
Study Arms  ICMJE
  • Experimental: Coffee A
    Intervention: Other: Coffee with water
  • Experimental: Coffee B
    Intervention: Other: Coffee with butter-I
  • Experimental: Coffee C
    Intervention: Other: Coffee with butter-II
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
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.
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04250740
Other Study ID Numbers  ICMJE 19-11-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amanda Wright, Ph.D., University of Guelph
Study Sponsor  ICMJE University of Guelph
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Guelph
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP