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OpenTrials
Completed

NCT Number: NCT05855837

Appetite Responses to Cereal Products

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

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Key information

Conditions

Satisfaction, Consumer Behavior Consumer Behavior

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Remote study, no physical facility

Minneapolis, Minnesota, 55426, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ready to Eat Cereal

Other

Cereal products available in retail stores

Primary outcomes

  1. Visual Analogue Scale for Hunger 0-240 minutes

    Time frame: 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.

  2. Visual Analogue Scale for Fullness 0-240 minutes

    Time frame: 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.

  3. Visual Analogue Scale for Satiation 0-240 minutes

    Time frame: 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.

  4. Visual Analogue Scale for Desire to Eat 0-240 minutes

    Time frame: 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.

  5. Visual Analogue Scale for Prospective Consumption 0-240 minutes

    Time frame: 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.

  6. Visual Analogue Scale for Satisfaction 0-240 minutes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

General Mills

Industry

Registry information

Official study title

Appetite Responses to Cereal Products: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 12, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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