NCT04404998

Brief Summary

The purpose of this study is to gain a better understanding of how energy density and cognitive framing of satiation using food information can influence consumption at a meal. This study also aims to investigate the influence of energy density and food information on sensory specific satiety (the decline in the subjective pleasantness of a food as it is eaten).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 11, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 3, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2021

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

March 11, 2020

Last Update Submit

December 8, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in food intake by weight

    Weight of food consumed measured in grams (g)

    Weeks 1, 2, 3, 4

  • Change in energy intake

    Energy content of food consumed measured in kilocalories (kcal)

    Weeks 1, 2, 3, 4

Secondary Outcomes (9)

  • Change in palatability rating of food samples

    Weeks 1, 2, 3, 4

  • Change in prospective consumption rating of food samples

    Weeks 1, 2, 3, 4

  • Change in hunger rating

    Weeks 1, 2, 3, 4

  • Change in fullness rating

    Weeks 1, 2, 3, 4

  • Change in test meal prospective consumption rating

    Weeks 1, 2, 3, 4

  • +4 more secondary outcomes

Study Arms (4)

Lower Energy Density & Lower Satiation

EXPERIMENTAL

Test meal with lower energy density and lower satiation information

Other: Lower Energy DensityOther: Lower Satiation

Lower Energy Density & Higher Satiation

EXPERIMENTAL

Test meal with lower energy density and higher satiation information

Other: Lower Energy DensityOther: Higher Satiation

Higher Energy Density & Lower Satiation

EXPERIMENTAL

Test meal with higher energy density and lower satiation information

Other: Higher Energy DensityOther: Lower Satiation

Higher Energy Density & Higher Satiation

EXPERIMENTAL

Test meal with higher energy density and higher satiation information

Other: Higher Energy DensityOther: Higher Satiation

Interventions

Test meal with lower energy density

Lower Energy Density & Higher SatiationLower Energy Density & Lower Satiation

Test meal with higher energy density

Higher Energy Density & Higher SatiationHigher Energy Density & Lower Satiation

Information on lower satiation

Higher Energy Density & Lower SatiationLower Energy Density & Lower Satiation

Information on higher satiation

Higher Energy Density & Higher SatiationLower Energy Density & Higher Satiation

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to attend all test meals
  • Be fully vaccinated against COVID-19
  • Regularly eat 3 meals/day
  • Being willing to avoid alcohol the day before and during test days
  • Have a body mass index greater than 18.0 kg/meters squared
  • Being willing to refrain from eating after 10 pm the evening before test sessions

You may not qualify if:

  • Being a smoker
  • Being an athlete in training
  • Being pregnant or breastfeeding at the time of screening
  • Have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
  • Dislike or inability to eat the test foods
  • Currently dieting to gain or lose weight
  • Have a health condition that affects appetite
  • Have participated in a similar study in our lab in the past year
  • Being a student, faculty, or staff member in nutritional sciences or psychology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior

Study Record Dates

First Submitted

March 11, 2020

First Posted

May 28, 2020

Study Start

August 3, 2021

Primary Completion

November 8, 2021

Study Completion

November 8, 2021

Last Updated

December 29, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations