NCT02369588

Brief Summary

This study tests the effect of serving larger portions of all foods in a meal on the outcome of food and energy intake. Using a crossover design, participants are served the meal once a week for four weeks and the portion sizes are varied at each meal. Some of the foods served at the meal are low in calorie density (calories per gram) and some are higher in calorie density. The aim is to determine whether intake in response to larger portions differs depending on characteristics of the subjects or of the foods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

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

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
Last Updated

February 24, 2015

Status Verified

February 1, 2015

Enrollment Period

9 months

First QC Date

February 17, 2015

Last Update Submit

February 17, 2015

Conditions

Feeding Behaviors

Outcome Measures

Primary Outcomes (3)

  • Differences in meal food intake

    Differences in weight of food consumed (grams) at the meals

    Weeks 1, 2, 3, and 4

  • Differences in meal energy intake

    Differences in energy of food consumed (kilocalories) at the meals

    Weeks 1, 2, 3, and 4

  • Differences in meal energy density

    Differences in energy density of food consumed (kilocalories per gram) at the meal

    Weeks 1, 2, 3, and 4

Secondary Outcomes (2)

  • Differences in hunger and satiety

    Weeks 1, 2, 3, and 4

  • Differences in ratings of food properties

    Weeks 1, 2, 3, and 4

Study Arms (4)

100% Portion Sizes

EXPERIMENTAL

Food portion size Test meal consists of baseline (100%) portion size of all foods

Other: Food portion size

133% Portion Sizes

EXPERIMENTAL

Food portion size Test meal consists of portion sizes of all foods that are 133% the size of baseline portions

Other: Food portion size

167% Portion Sizes

EXPERIMENTAL

Food portion size Test meal consists of portion sizes of all foods that are 167% the size of baseline portions

Other: Food portion size

200% Portion Sizes

EXPERIMENTAL

Food portion size Test meal consists of portion sizes of all foods that are 200% the size of baseline portions

Other: Food portion size

Interventions

Food portion sizeOTHER
100% Portion Sizes133% Portion Sizes167% Portion Sizes200% Portion Sizes

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index of 18 to 40 kg/square meter
  • Regularly eat three meals per day
  • Willing to eat foods served at test meals

You may not qualify if:

  • Food allergies or restrictions
  • Dieting to gain or lose weight
  • Taking medications known to affect appetite
  • Smoker
  • Athlete in training
  • Currently pregnant or breast-feeding
  • Questionnaire score indicative of depression
  • Questionnaire score indicative of disordered eating attitudes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

  • Roe LS, Kling SMR, Rolls BJ. What is eaten when all of the foods at a meal are served in large portions? Appetite. 2016 Apr 1;99:1-9. doi: 10.1016/j.appet.2016.01.001. Epub 2016 Jan 5.

    PMID: 26767612DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Barbara J. Rolls

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
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

February 17, 2015

First Posted

February 24, 2015

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 24, 2015

Record last verified: 2015-02

Locations

US(1)