Appetite Responses to Breakfast Bar Product

Appetite Responses to Breakfast Bar Product: 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: Breakfast Bar

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55430
      • Remote

Participation Criteria

Eligibility Criteria

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

Description

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

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention (i.e., no food provided)
Experimental: Breakfast Bar; Packaged breakfast bar available in retail stores	Other: Breakfast Bar; Packaged breakfast bar product available in retail stores

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 minutes
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.	240 minutes
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 minutes
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 minutes
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 minutes

Collaborators and Investigators

• Sponsor: General Mills

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2024
• Primary Completion (Actual): October 24, 2024
• Study Completion (Actual): October 24, 2024

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 597

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
• product manufactured in and exported from the U.S.: No