HealthyNCT05287516
Validation of a Digital Visual Analogue Scale for Appetite Measurement
A study testing Breakfast meal in people with Healthy, run by General Mills at 1 site in United States.
Trial summary
The objective of the study is to validate a newly developed digital visual analog scales with a mobile app for measuring human appetite and compare it with a traditional paper-based visual analog scales for appetite measurement. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Breakfast meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 30 May 2022
- 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.
- Body mass index 20-29.9 kg/m² (based on self-reported weight and height).
- Understand the study procedures.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Willing to follow study procedures on test days.
- Willing to abstain from strenuous exercise, 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, sensitivity, or intolerance to any food or food ingredients
- Participating in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
- Taking medications that affect appetite, metabolism, or blood pressure
- Presence of acute diseases or infection
- Presence or history of chronic diseases
Show all 11Show fewer
- Diagnosed with eating disorders
- Restraint eaters
- Lost or gained 5 pounds or more in the past 3 months
- On a weight-loss diet, or undergoing intermittent fasting
- COVID-19 infection in the past 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Remote study, No physical facility
Minneapolis, Minnesota, 55427
About this study
Official title: Use of a Digital Visual Analog Scale With Smart Phones for Appetite Measures in the Real World: A Validation Study
The objective of the study is to validate a newly developed digital visual analog scales with a mobile app for measuring human appetite and compare it with a traditional paper-based visual analog scales for appetite measurement.
- Conditions
- Healthy
- Being tested
- Breakfast meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast mealOther
A meal consisting of breakfast biscuits and water.
| Study group | Role | What they receive |
|---|---|---|
| Breakfast meal with 460 kcal | Experimental | Not described Receives: Other: Breakfast meal |
| Breakfast meal with 230 kcal | Active comparator | Not described Receives: Other: Breakfast meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve for Hunger 0-240 min
Area Under the Curve for Hunger 0-240 min
Measured: 0-240 min
Area Under the Curve for Fullness 0-240 min
Area Under the Curve for Fullness 0-240 min
Measured: 0-240 min
Area Under the Curve for Desire to Eat 0-240 min
Area Under the Curve for Desire to Eat 0-240 min
Measured: 0-240 min
Area Under the Curve for Prospective Consumption 0-240 min
Area Under the Curve for Prospective Consumption 0-240 min
Measured: 0-240 min
Area Under the Curve for Satiety 0-240 min
Area Under the Curve for Satiety 0-240 min
Measured: 0-240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Apr 2022
- Primary completion16 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 130 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
- NCT05287516
- Sponsor's protocol ID
- 2022/03/11
- Status last verified
- Nov 2022
- First submitted
- 10 Mar 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- 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 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Digital Visual Analog Scale With Smart Phones for Appetite Measures in the Real World: A Validation Study
- ClinicalTrials.gov ID
- NCT05287516
- Acronym / sponsor ID
- 2022/03/11
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- General MillsIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 18 Mar 2022 (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 objective of the study is to validate a newly developed digital visual analog scales with a mobile app for measuring human appetite and compare it with a traditional paper-based visual analog scales for appetite measurement.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breakfast meal with 460 kcal | Experimental | Other: Breakfast meal |
| Breakfast meal with 230 kcal | Active comparator | Other: Breakfast meal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy adults 18-70 years.
- Body mass index 20-29.9 kg/m² (based on self-reported weight and height).
- Understand the study procedures.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Willing to follow study procedures on test days.
Key exclusion criteria (11 listed)
- Pregnant or lactating women, or women who are planning to become pregnant during the study
- Known food allergies, sensitivity, or intolerance to any food or food ingredients
- Participating in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
- Taking medications 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 |
|---|---|---|
| Breakfast mealA meal consisting of breakfast biscuits and water. | Other | Breakfast meal with 230 kcal, Breakfast meal with 460 kcal |
Primary outcome
Area Under the Curve for Hunger 0-240 min
Time frame: 0-240 min
Area Under the Curve for Hunger 0-240 min
Area Under the Curve for Fullness 0-240 min
Time frame: 0-240 min
Area Under the Curve for Fullness 0-240 min
Area Under the Curve for Desire to Eat 0-240 min
Time frame: 0-240 min
Area Under the Curve for Desire to Eat 0-240 min
Area Under the Curve for Prospective Consumption 0-240 min
Time frame: 0-240 min
Area Under the Curve for Prospective Consumption 0-240 min
Area Under the Curve for Satiety 0-240 min
Time frame: 0-240 min
Area Under the Curve for Satiety 0-240 min
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 16 Nov 2022.
- 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 Breakfast meal in people with Healthy, 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 7 inclusion and 11 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 16 Nov 2022. 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?
Area Under the Curve for Hunger 0-240 min (time frame: 0-240 min). The study lists 5 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 16 Nov 2022.