The Influence of Energy Density and Information on Meal Intake in Adults

Sponsor

Penn State University (Other)

Overall Status

Terminated

CT.gov ID

NCT04404998

Collaborator

(none)

Enrollment

Location

Arms

3.2

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Feeding Behavior	Other: Lower Energy Density Other: Higher Energy Density Other: Lower Satiation Other: Higher Satiation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Lunch Meal Study for Men and Women

Actual Study Start Date :

Aug 3, 2021

Actual Primary Completion Date :

Nov 8, 2021

Actual Study Completion Date :

Nov 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lower Energy Density & Lower Satiation Test meal with lower energy density and lower satiation information	Other: Lower Energy Density Test meal with lower energy density Other: Lower Satiation Information on lower satiation
Experimental: Lower Energy Density & Higher Satiation Test meal with lower energy density and higher satiation information	Other: Lower Energy Density Test meal with lower energy density Other: Higher Satiation Information on higher satiation
Experimental: Higher Energy Density & Lower Satiation Test meal with higher energy density and lower satiation information	Other: Higher Energy Density Test meal with higher energy density Other: Lower Satiation Information on lower satiation
Experimental: Higher Energy Density & Higher Satiation Test meal with higher energy density and higher satiation information	Other: Higher Energy Density Test meal with higher energy density Other: Higher Satiation Information on higher satiation

Outcome Measures

Primary Outcome Measures

Change in food intake by weight [Weeks 1, 2, 3, 4]
Weight of food consumed measured in grams (g)
Change in energy intake [Weeks 1, 2, 3, 4]
Energy content of food consumed measured in kilocalories (kcal)

Secondary Outcome Measures

Change in palatability rating of food samples [Weeks 1, 2, 3, 4]
Difference between post-meal and pre-meal palatability of the food samples measured by Visual Analogue Scales (ranging from 0 mm to 100 mm) to assess Sensory-Specific Satiety
Change in prospective consumption rating of food samples [Weeks 1, 2, 3, 4]
Difference between post-meal and pre-meal prospective consumption of food samples measured by Visual Analogue Scales (ranging from 0 mm to 100 mm) to assess Sensory-Specific Satiety
Change in hunger rating [Weeks 1, 2, 3, 4]
Difference between post-meal and pre-meal hunger measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
Change in fullness rating [Weeks 1, 2, 3, 4]
Difference between post-meal and pre-meal fullness measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
Change in test meal prospective consumption rating [Weeks 1, 2, 3, 4]
Difference in prospective consumption measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
Change in test meal fillingness rating [Weeks 1, 2, 3, 4]
Difference in fillingness measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
Change in test meal palatability rating [Weeks 1, 2, 3, 4]
Difference in palatability of the test meal measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
Change in estimation of proportion of test meal consumed [Weeks 1, 2, 3, 4]
Difference in estimation of proportion of test meal consumed measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
Change in estimation of energy content of test meal consumed [Weeks 1, 2, 3, 4]
Difference in estimation of energy content of test meal consumed measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University	University Park	Pennsylvania	United States	16802

Sponsors and Collaborators

Penn State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Barbara J. Rolls, Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior, Penn State University

ClinicalTrials.gov Identifier:

NCT04404998

Other Study ID Numbers:

FoodED601

First Posted:

May 28, 2020

Last Update Posted:

Dec 29, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 29, 2021