Appetite Responses to Cereal Products

Satisfaction, Consumer Clinical Trial

Official title:

Appetite Responses to Cereal Products: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05855837
• Other study ID #: 2023/03/21
• Status: Completed
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: July 2023
• Source: General Mills
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: August 30, 2023
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Satisfaction, Consumer

Intervention

Other:
• Ready to Eat Cereal
Cereal products available in retail stores

Locations

Country	Name	City	State
United States	Remote study, no physical facility	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
General Mills

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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