Appetite Responses to Cereal Products

Appetite Responses to Cereal Products: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Satisfaction, Consumer
• Intervention / Treatment: Other: Ready to Eat Cereal

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taylor Banh, PhD; Email: taylor.banh@genmills.com

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55426
      • Remote study, no physical facility
      • Contact: Taylor Banh, PhD; Email: taylor.banh@genmills.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: General Mills

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): June 9, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023/03/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No