Validation of a Digital Visual Analogue Scale for Appetite Measurement

Healthy Clinical Trial

Official title:

Use of a Digital Visual Analog Scale With Smart Phones for Appetite Measures in the Real World: A Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05287516
• Other study ID #: 2022/03/11
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: May 30, 2022

Study information

• Verified date: November 2022
• Source: General Mills
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 30, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Breakfast meal
A meal consisting of breakfast biscuits and water.

Locations

Country	Name	City	State
United States	Remote study, No physical facility	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
General Mills

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve for Hunger 0-240 min	Area Under the Curve for Hunger 0-240 min	0-240 min
Primary	Area Under the Curve for Fullness 0-240 min	Area Under the Curve for Fullness 0-240 min	0-240 min
Primary	Area Under the Curve for Desire to Eat 0-240 min	Area Under the Curve for Desire to Eat 0-240 min	0-240 min
Primary	Area Under the Curve for Prospective Consumption 0-240 min	Area Under the Curve for Prospective Consumption 0-240 min	0-240 min
Primary	Area Under the Curve for Satiety 0-240 min	Area Under the Curve for Satiety 0-240 min	0-240 min