Appetite Responses to Cereal Products

NCT05855837 | Completed

• 1 other identifier: 2023/03/21
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Satisfaction, Consumer

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

Cereal Product 1

EXPERIMENTAL

Ready to Eat Cereal Product 1 with 6 oz of skim milk

Other: Ready to Eat Cereal

Cereal Product 2

EXPERIMENTAL

Ready to Eat Cereal Product 2 with 6 oz of skim milk

Other: Ready to Eat Cereal

Control

NO INTERVENTION

No intervention (i.e., no food provided)

Interventions

Ready to Eat Cereal OTHER

Cereal products available in retail stores

Cereal Product 1; Cereal Product 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Mills: lead

Study Sites (1)

Remote study, no physical facility

Minneapolis, Minnesota, 55426, United States

Location

MeSH Terms

Conditions

Consumer Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 12, 2023
• Study Start: June 5, 2023
• Primary Completion: June 9, 2023
• Study Completion: August 30, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)