Appetite Responses to Cereal Products

Study Overview
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Brief Summary
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The purpose of this clinical trial is to investigate appetite responses to 2 cereal products in healthy adults.

Official Title
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Appetite Responses to Cereal Products: A Randomized Controlled Trial

Conditions
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Satisfaction, Consumer

Intervention / Treatment
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* Other: Ready to Eat Cereal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults 18-70 years old Habitual cereal consumers (at least several times per month) Body mass index 18.5-24.9 kg/m2 (based on self-reported weight and height Understand and willing to follow the study procedures Willing to drink skim milk Willing to maintain habitual diet, physical activity pattern, and body weight throughout the study Willing to abstain from strenuous exercise and 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 Participation in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification Taking medication(s) 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 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 cereal products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cereal Product 1<br>Ready to Eat Cereal Product 1 with 6 oz of skim milk | Other: Ready to Eat Cereal<br>* Cereal products available in retail stores<br>|
| Experimental: Cereal Product 2<br>Ready to Eat Cereal Product 2 with 6 oz of skim milk | Other: Ready to Eat Cereal<br>* Cereal products available in retail stores<br>|
| No Intervention: Control<br>No intervention (i.e., no food provided) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale for Hunger 0-240 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. | 240 minutes | 
| Visual Analogue Scale for Fullness 0-240 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. | 240 min | 
| Visual Analogue Scale for Satiation 0-240 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. | 0-240 min | 
| Visual Analogue Scale for Desire to Eat 0-240 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. | 240 min | 
| Visual Analogue Scale for Prospective Consumption 0-240 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. | 240 min | 
| Visual Analogue Scale for Satisfaction 0-240 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. | 240 min |