NCT04836416

Brief Summary

This study will examine appetitive sensation variability and the relationship between appetitive sensations and energy intake. Investigators believe the methods for assessing and interpretation of appetitive sensations are problematic and mask the true influence of these sensations on eating. This limits the development of guidelines for weight management. To gain a better understanding of the relationship, investigators will track hourly appetite sensations and map these to eating events via time-series analyses to gain new insights on the directionality and magnitude of these relationships. Also, investigators will also examine the association of apetitive ratings with age or gender. This will allow the development of more effective weight management recommendations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

April 5, 2021

Last Update Submit

May 6, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Hunger

    A positive association between hunger and eating frequency.

    4 months

  • Thirst

    A positive association between thirst and energy intake from beverages.

    4 Months

  • Fullness

    A positive association between fullness and portion size.

    4 Months

  • Energy Intake

    A positive association between combined hunger (determinant of eating frequency) and fullness (determinant of portion size) ratings and energy intake.

    4 Months

  • Age

    A negative association between appetitive sensation intensities and age.

    4 Months

  • Gender

    No significant association between appetitive sensation intensities and gender.

    4 Months

Study Arms (6)

Young Adult/Normal

Age 18-35, BMI 18.5-24.9

Other: Observational

Young Adult/Overweight and Obese

Age18-35, BMI greater than 25.0

Other: Observational

Adult/Normal

Age 36-50, BMI 18.5-24.9

Other: Observational

Adult/Overweight and Obese

Age 36-50, BMI greater than 25.0

Other: Observational

Older Adult/Nornal

Age 51-65, BMI 18.5-24.9

Other: Observational

Older Adult/Overweight and Obese

Age 51-65, BMI greater than 25.0

Other: Observational

Interventions

Observational

Adult/NormalAdult/Overweight and ObeseOlder Adult/NornalOlder Adult/Overweight and ObeseYoung Adult/NormalYoung Adult/Overweight and Obese

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

community sample

You may qualify if:

  • Age 18-65 years.
  • Body weight fluctuation of \<2.5 kg in the past 3 months.

You may not qualify if:

  • Having an acute disease.
  • Planning to initiate or terminate medication known to affect appetite.
  • Planning to initiate or terminate lifestyle behaviors that could affect energy balance
  • Age \<18 or \>65 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue Univeristy

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Richard D Mattes, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Richard Mattes PhD, RD

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 8, 2021

Study Start

April 2, 2021

Primary Completion

August 2, 2022

Study Completion

December 31, 2022

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations