Validation of a Digital Visual Analogue Scale for Appetite Measurement

• Sponsor: General Mills (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05287516
• Collaborator: (none)
• Enrollment: 130
• Arms: 2
• Anticipated Duration (Months): 9.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Breakfast meal	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Use of a Digital Visual Analog Scale With Smart Phones for Appetite Measures in the Real World: A Validation Study
• Anticipated Study Start Date: Mar 21, 2022
• Anticipated Primary Completion Date: Apr 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Breakfast meal with 460 kcal	Other: Breakfast meal; A meal consisting of breakfast biscuits and water.
Active Comparator: Breakfast meal with 230 kcal	Other: Breakfast meal; A meal consisting of breakfast biscuits and water.

Outcome Measures

Primary Outcome Measures

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

   Area Under the Curve for Hunger 0-240 min

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

   Area Under the Curve for Fullness 0-240 min

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

   Area Under the Curve for Desire to Eat 0-240 min

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

   Area Under the Curve for Prospective Consumption 0-240 min

5. Area Under the Curve for Satiety 0-240 min [0-240 min]

   Area Under the Curve for Satiety 0-240 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.

• 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.

Contacts and Locations

Locations

No locations specified.

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: NCT05287516
• Other Study ID Numbers: 2022/03/11
• First Posted: Mar 18, 2022
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• 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 Mar 18, 2022