Appetite Responses to Breakfast Bar Product: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale for Hunger 0-240 minutes
Study Overview
Brief Summary
The purpose of this clinical trial is to investigate appetite responses to 2 cereal products in healthy adults.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy adults 18-70 years
- •Habitual snack bar consumers (at least several times per month)
- •Body mass index 18.5-29.9 kg/m2 (based on self-reported weight and height)
- •Understand and willing to follow the study procedures
- •Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial
- •Willing to abstain from strenuous exercise, consuming alcoholic drinks 24 hours before the test day
- •Willing to provide informed consent to participate in the study
Exclusion Criteria
- •Pregnant or lactating women, or women who are planning to become pregnant during the study
- •Known food allergies, sensitivities, or intolerance to any food or food ingredients
- •Participating in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
- •Taking medications that affect appetite, metabolism or blood pressure
- •Presence of acute diseases or infection
- •Presence or history of chronic diseases
- •Diagnosed with an eating disorder
- •Restraint eaters as determined by a score >4 from the Dutch Eating Behavior Questionnaire
- •Lost or gained 5 or more pounds in the past 3-months
- •On a weight loss diet or undergoing intermittent fasting
- •COVID-19 infection within the past 3 months
- •Subjects who do not eat bar products
Arms & Interventions
Breakfast Bar
Packaged breakfast bar available in retail stores
Intervention: Breakfast Bar (Other)
Control
No intervention (i.e., no food provided)
Outcomes
Primary Outcomes
Visual Analogue Scale for Hunger 0-240 minutes
Time Frame: 240 minutes
Visual Analogue Scale for "how hungry are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more hunger. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a lower mm change from baseline indicates a better outcome.
Visual Analogue Scale for Fullness 0-240 minutes
Time Frame: 240 minutes
Visual Analogue Scale for "how full are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more fullness. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a higher mm change from baseline indicates a better outcome.
Visual Analogue Scale for Satiation 0-240 minutes
Time Frame: 240 minutes
Visual Analogue Scale for "how satiated are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more satiation. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a higher mm change from baseline indicates a better outcome.
Visual Analogue Scale for Desire to Eat 0-240 minutes
Time Frame: 240 minutes
Visual Analogue Scale for "how strong is your desire to eat right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more desire to eat. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a lower mm change from baseline indicates a better outcome.
Visual Analogue Scale for Prospective Consumption 0-240 minutes
Time Frame: 240 minutes
Visual Analogue Scale for "how much do you think you can eat right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more prospective consumption. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a lower mm change from baseline indicates a better outcome.
Visual Analogue Scale for Satisfaction 0-240 minutes
Time Frame: 240 minutes
Visual Analogue Scale for "how satisfied are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more satisfaction. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a higher mm change from baseline indicates a better outcome.
Secondary Outcomes
No secondary outcomes reported