Validation of a Digital Visual Analogue Scale for Appetit... | NCT05287516

Studies
Validation of a Digital Visual Analogue Scale for Appetite Measurement

NCT05287516

Sponsor

General Mills

Status

Completed

Last Update Posted

Nov 16, 2022Actual

Enrollment

130Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Breakfast meal

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Actual

Primary Completion Date

May 16, 2022Actual

Completion Date

May 30, 2022Actual

First Submitted Date

Mar 10, 2022

First Submission Date that Met QC Criteria

Mar 10, 2022

First Posted Date

Mar 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2022

Last Update Posted Date

Nov 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breakfast meal with 460 kcal	Experimental		Other: Breakfast meal
Breakfast meal with 230 kcal	Active Comparator		Other: Breakfast meal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breakfast meal	Other	A meal consisting of breakfast biscuits and water.	Breakfast meal with 230 kcal Breakfast meal with 460 kcal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Curve for Hunger 0-240 min	Area Under the Curve for Hunger 0-240 min	0-240 min
Area Under the Curve for Fullness 0-240 min	Area Under the Curve for Fullness 0-240 min	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	0-240 min
Area Under the Curve for Prospective Consumption 0-240 min	Area Under the Curve for Prospective Consumption 0-240 min	0-240 min
Area Under the Curve for Satiety 0-240 min	Area Under the Curve for Satiety 0-240 min	0-240 min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Remote study, No physical facility		Minneapolis	Minnesota	55427	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D062407	Meals
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena