Appetite Responses to Cereal Products

Not Applicable

Completed

• Conditions: Satisfaction, Consumer

• Registration Number: NCT05855837
• Lead Sponsor: General Mills

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-12
• Study Start: 2023-06-05
• Primary Completion: 2023-06-09
• Status Verified: 2023-07
• Study Completion: 2023-08-30
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale for Desire to Eat 0-240 minutes	240 min	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 Fullness 0-240 minutes	240 min	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 Hunger 0-240 minutes	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 Satisfaction 0-240 minutes	240 min	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.
Visual Analogue Scale for Satiation 0-240 minutes	0-240 min	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 Prospective Consumption 0-240 minutes	240 min	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.

Trial Locations

Locations (1)

Remote study, no physical facility; 🇺🇸 Minneapolis, Minnesota, United States