NCT03886428

Brief Summary

The purpose of this study is to gain a better understanding of the satiation measures that influence human eating behavior in regard to intake of large portion sizes at a meal. The investigators hypothesize that satiation measures will influence the magnitude of the portion size effect at a meal. Additionally, other individual characteristics will be examined for their influence on the portion size effect. The portion size effect will be measured by serving a test meal once a week for four weeks in which the portion size of the entree will be varied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

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 14, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 21, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

March 14, 2019

Last Update Submit

March 11, 2020

Conditions

Feeding Behavior

Outcome Measures

Primary Outcomes (2)

  • Change in energy intake

    Calculated energy intake (kcal) based on weight and energy density of food consumed

    Weeks 1, 2, 3, 4

  • Change in intake by weight

    Weights (grams) of all foods consumed

    Weeks 1, 2, 3, 4

Secondary Outcomes (16)

  • Change in bite count

    Weeks 1, 2, 3, 4

  • Change in meal duration

    Weeks 1, 2, 3, 4

  • Change in mean bite rate

    Weeks 1, 2, 3, 4

  • Change in mean bite size

    Weeks 1, 2, 3, 4

  • Change in mean eating rate

    Weeks 1, 2, 3, 4

  • +11 more secondary outcomes

Other Outcomes (11)

  • Rating of the size of the entree compared to participants' usual portion

    At the start of the test meal in weeks 1, 2, 3, 4

  • Rating of how filling participants expect this amount of food to be

    At the start of the test meal in weeks 1, 2, 3, 4

  • Rating of pleasantness of taste of entree

    At the start of the test meal in weeks 1, 2, 3, 4

  • +8 more other outcomes

Study Arms (4)

100% Portion Size

EXPERIMENTAL

Test meal with portion size 100% of baseline

Other: 100% portion size

125% Portion Size

EXPERIMENTAL

Test meal with portion size 125% of baseline

Other: 125% portion size

150% Portion Size

EXPERIMENTAL

Test meal with portion size 150% of baseline

Other: 150% portion size

175% Portion Size

EXPERIMENTAL

Test meal with portion size 175% of baseline

Other: 175% portion size

Interventions

100% portion sizeOTHER

Entree portion size 100% of baseline

100% Portion Size
125% portion sizeOTHER

Entree portion size 125% of baseline

125% Portion Size
150% portion sizeOTHER

Entree portion size 150% of baseline

150% Portion Size
175% portion sizeOTHER

Entree portion size 175% of baseline

175% Portion Size

Eligibility Criteria

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

You may qualify if:

  • Be willing and able to travel to Penn State University Park campus weekly for meals
  • Be a man or woman 18 - 70 years old
  • Regularly eat 3 meals/day
  • Be willing to avoid alcohol the day before and during test days
  • Have a body mass index between 18.0 and 35.0 kg/m\*m
  • Be willing to refrain from eating after 10 pm the evening before test sessions
  • Be willing to participate in all study procedures

You may not qualify if:

  • Must not be a smoker
  • Must not be an athlete in training
  • Must not be 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 be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions)
  • Must not be 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
  • Must not be a student, faculty, or staff member in nutritional sciences or psychology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Portion Size

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

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 14, 2019

First Posted

March 22, 2019

Study Start

May 21, 2019

Primary Completion

December 11, 2019

Study Completion

December 13, 2019

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)