NCT05287516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

March 10, 2022

Last Update Submit

November 11, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Breakfast meal with 460 kcal

EXPERIMENTAL
Other: Breakfast meal

Breakfast meal with 230 kcal

ACTIVE COMPARATOR
Other: Breakfast meal

Interventions

A meal consisting of breakfast biscuits and water.

Breakfast meal with 230 kcalBreakfast meal with 460 kcal

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Remote study, No physical facility

Minneapolis, Minnesota, 55427, United States

Location

MeSH Terms

Interventions

Breakfast

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 18, 2022

Study Start

April 1, 2022

Primary Completion

May 16, 2022

Study Completion

May 30, 2022

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations