NCT05177367

Brief Summary

The primary purpose of this study is to investigate the combined effects of meal variety and portion size on food intake at a meal. The study will also investigate relationships with eating microstructure such as eating rate and bite size. Additionally, other individual characteristics will be examined for their influence on the effects of variety and portion size on meal intake.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 15, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 20, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2023

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

December 15, 2021

Last Update Submit

February 17, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in intake by weight

    Weight (grams) of all meal components consumed

    Weeks 1, 2, 3, 4, 5, 6

  • Change in energy intake

    Energy intake (kilocalories) of all meal components consumed, calculated from weight and energy density

    Weeks 1, 2, 3, 4, 5, 6

Secondary Outcomes (15)

  • Change in bite count

    Weeks 1, 2, 3, 4, 5, 6

  • Change in meal duration

    Weeks 1, 2, 3, 4, 5, 6

  • Change in mean eating rate

    Weeks 1, 2, 3, 4, 5, 6

  • Change in mean bite size

    Weeks 1, 2, 3, 4, 5, 6

  • Change in sip count

    Weeks 1, 2, 3, 4, 5, 6

  • +10 more secondary outcomes

Study Arms (6)

Sequential Variety, Small Portion

EXPERIMENTAL

3 courses each consisting of a different food served in a small portion.

Other: Sequential VarietyOther: Small portion

Sequential Variety, Large Portion

EXPERIMENTAL

3 courses each consisting of a different food served in a large portion.

Other: Sequential VarietyOther: Large Portion

Simultaneous Variety, Small Portion

EXPERIMENTAL

3 courses each consisting of 3 foods served in small portions.

Other: Simultaneous VarietyOther: Small portion

Simultaneous Variety, Large Portion

EXPERIMENTAL

3 courses each consisting of 3 foods served in large portions.

Other: Simultaneous VarietyOther: Large Portion

Single Food, Small Portion

EXPERIMENTAL

3 courses each consisting of the same food served in a small portion.

Other: Single FoodOther: Small portion

Single Food, Large Portion

EXPERIMENTAL

3 courses each consisting of the same food served in a large portion.

Other: Single FoodOther: Large Portion

Interventions

3 courses each consisting of a different food

Sequential Variety, Large PortionSequential Variety, Small Portion

3 courses each consisting of 3 foods

Simultaneous Variety, Large PortionSimultaneous Variety, Small Portion

3 courses each consisting of the same food

Single Food, Large PortionSingle Food, Small Portion

Small meal portion size

Sequential Variety, Small PortionSimultaneous Variety, Small PortionSingle Food, Small Portion

Large meal portion size

Sequential Variety, Large PortionSimultaneous Variety, Large PortionSingle Food, Large Portion

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
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 fully vaccinated against COVID-19
  • Be a woman 20 - 65 years old
  • Regularly eat 3 meals/day
  • Be willing to refrain from drinking 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
  • Must not have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
  • Must not dislike or be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions)
  • Must not have a high variability in liking of the test foods
  • Must not be currently dieting to gain or lose weight
  • Must not have a health condition that affects appetite
  • Must not 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)

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

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Food

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages
0

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

December 15, 2021

First Posted

January 4, 2022

Study Start

February 20, 2022

Primary Completion

January 20, 2023

Study Completion

January 27, 2023

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations