NCT05485168

Brief Summary

The primary purpose of this study is to investigate the combined effects of sequential meal variety and portion size on food intake at a meal. Additionally, other individual characteristics will be examined for their influence on the effects of simultaneous variety and portion size on meal intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

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

July 28, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 6, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

July 28, 2022

Last Update Submit

September 21, 2023

Conditions

Eating Behavior

Outcome Measures

Primary Outcomes (2)

  • Change in intake by weight

    Weight (grams) of all meal components consumed

    Weeks 1, 2, 3, 4

  • Change in energy intake

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

    Weeks 1, 2, 3, 4

Secondary Outcomes (15)

  • Change in bite count

    Weeks 1, 2, 3, 4

  • Change in active eating time

    Weeks 1, 2, 3, 4

  • Change in mean eating rate

    Weeks 1, 2, 3, 4

  • Change in mean bite size

    Weeks 1, 2, 3, 4

  • Change in sip count

    Weeks 1, 2, 3, 4

  • +10 more secondary outcomes

Study Arms (4)

Sequential Variety, Small Portion

EXPERIMENTAL

3 different foods served in a small portion in 3 successive courses

Other: Sequential VarietyOther: Small Portion

Sequential Variety, Large Portion

EXPERIMENTAL

3 different foods served in a large portion in 3 successive courses

Other: Sequential VarietyOther: Large Portion

Single-Food, Small Portion

EXPERIMENTAL

1 food served in a small portion in 3 successive courses

Other: Single-FoodOther: Small Portion

Single-Food, Large Portion

EXPERIMENTAL

1 food served in a large portion in 3 successive courses

Other: Single-FoodOther: Large Portion

Interventions

Sequential VarietyOTHER

3 different foods served in 3 successive courses

Sequential Variety, Large PortionSequential Variety, Small Portion
Single-FoodOTHER

1 food served in 3 successive courses

Single-Food, Large PortionSingle-Food, Small Portion
Small PortionOTHER

Small meal portion size

Sequential Variety, Small PortionSingle-Food, Small Portion
Large PortionOTHER

Large meal portion size

Sequential 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

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

July 28, 2022

First Posted

August 3, 2022

Study Start

September 6, 2022

Primary Completion

April 3, 2023

Study Completion

April 7, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)