Satisfaction, ConsumerNCT05855837
Appetite Responses to Cereal Products
A study testing Ready to Eat Cereal in people with Satisfaction, Consumer, run by General Mills at 1 site in United States.
Trial summary
The purpose of this clinical trial is to investigate appetite responses to 2 cereal products in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Consumer
- What is being tested?
- Ready to Eat Cereal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2023to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Remote study, no physical facility
Minneapolis, Minnesota, 55426
About this study
Official title: Appetite Responses to Cereal Products: A Randomized Controlled Trial
The purpose of this clinical trial is to investigate appetite responses to 2 cereal products in healthy adults.
- Conditions
- Satisfaction, Consumer
- Being tested
- Ready to Eat Cereal
- Medical subject headings
- Consumer Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready to Eat CerealOther
Cereal products available in retail stores
| Study group | Role | What they receive |
|---|---|---|
| Cereal Product 1 | Experimental | Ready to Eat Cereal Product 1 with 6 oz of skim milk Receives: Other: Ready to Eat Cereal |
| Cereal Product 2 | Experimental | Ready to Eat Cereal Product 2 with 6 oz of skim milk Receives: Other: Ready to Eat Cereal |
| Control | No intervention | No intervention (i.e., no food provided) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start5 Jun 2023
- Primary completion9 Jun 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, ConsumerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Mills
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855837
- Sponsor's protocol ID
- 2023/03/21
- Status last verified
- Jul 2023
- First submitted
- 2 May 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appetite Responses to Cereal Products: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05855837
- Acronym / sponsor ID
- 2023/03/21
- Conditions
- Satisfaction, Consumer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- General MillsIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to investigate appetite responses to 2 cereal products in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cereal Product 1 | Experimental | Other: Ready to Eat CerealReady to Eat Cereal Product 1 with 6 oz of skim milk |
| Cereal Product 2 | Experimental | Other: Ready to Eat CerealReady to Eat Cereal Product 2 with 6 oz of skim milk |
| Control | No intervention | –No intervention (i.e., no food provided) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ready to Eat CerealCereal products available in retail stores | Other | Cereal Product 1, Cereal Product 2 |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ready to Eat Cereal in people with Satisfaction, Consumer, run by General Mills at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for Hunger 0-240 minutes (time frame: 240 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.