NCT04250740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

January 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

March 27, 2025

Status Verified

December 1, 2024

Enrollment Period

4.6 years

First QC Date

January 28, 2020

Last Update Submit

March 24, 2025

Conditions

Appetitive Behavior

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Please indicate on the line the creaminess of the coffee

    0 - 180 minutes

  • Please indicate on the line how hungry you are

    30 - 180 minutes

  • Lunch meal food intake

    180 minutes

Other Outcomes (1)

  • Gastric emptying

    0, 30, 60, 90, 120, 150, and 180 minutes

Study Arms (3)

Coffee A

EXPERIMENTAL
Other: Coffee with butter-1

Coffee B

EXPERIMENTAL
Other: Coffee with butter-II

Coffee C

EXPERIMENTAL
Other: Coffee with butter-III

Interventions

Coffee with butter-1OTHER

250 mL brewed black coffee with hazelnut flavouring and 50 g water

Coffee A
Coffee with butter-IIOTHER

250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-I

Coffee B
Coffee with butter-IIIOTHER

250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-II

Coffee C

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWe aim to recruit adults with regular menstrual periods, whereby we would include an eligible menstruating participant who identifies as a gender other than female.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Generally healthy women
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Coffee

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 31, 2020

Study Start

January 30, 2020

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

March 27, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)