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Appetite Responses to Cereal Products

Sponsor
General Mills (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05855837
Collaborator
(none)
240
Enrollment
1
Location
3
Arms
1.3
Anticipated Duration (Months)
187.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Ready to Eat Cereal
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Appetite Responses to Cereal Products: A Randomized Controlled Trial
Anticipated Study Start Date :
May 22, 2023
Anticipated Primary Completion Date :
May 29, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Area Under the Curve for Hunger 0-240 minutes [240 minutes]

  2. Area Under the Curve for Fullness 0-240 minutes [240 min]

  3. Area Under the Curve for Satiation 0-240 minutes [0-240 min]

  4. Area Under the Curve for Desire to Eat 0-240 minutes [240 min]

  5. Area Under the Curve for Prospective Consumption 0-240 minutes [240 min]

  6. Area Under the Curve for Satisfaction 0-240 minutes [240 min]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Remote study, no physical facility Minneapolis Minnesota United States 55426

Sponsors and Collaborators

  • General Mills

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
General Mills
ClinicalTrials.gov Identifier:
NCT05855837
Other Study ID Numbers:
  • 2023/03/21
First Posted:
May 12, 2023
Last Update Posted:
May 12, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 12, 2023