NCT02505230

Brief Summary

This study will investigate the energy consumed from an entree with high- or low-volume vegetables incorporated into the entree or served along side of the entree, in normal weight adults.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

July 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

6.5 years

First QC Date

July 21, 2015

Last Update Submit

April 1, 2025

Conditions

VolumeEnergy DensityMeal Presentation

Outcome Measures

Primary Outcomes (6)

  • Grams of main pasta entree consumed

    20 minutes

  • Grams of zucchini and squash consumed

    20 minutes

  • Level of hunger

    baseline

  • Level of fullness

    baseline

  • Level of liking

    baseline

  • Energy intake

    20 minutes

Study Arms (4)

Meal Order 1

EXPERIMENTAL

\[P,P+S,HVP,LVP\] For the PASTA (P) condition, participants will view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) and no vegetables. For the PASTA+SIDE (P+S) condition, participants will view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) with a side of mixed zucchini and squash (cut in 1/2 inch half-moon slices). For the HIGH-VOLUME PASTA (HVP) condition, participants view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) mixed with zucchini and squash (cut in 1/2 inch half-moon slices). For the LOW-VOLUME PASTA (LVP) condition, participants will view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) mixed with grated zucchini and squash (chopped in food processor).

Behavioral: Eating

Meal Order 2

EXPERIMENTAL

\[P+S,HVP,LVP,P\] For the PASTA+SIDE (P+S) condition, participants will view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) with a side of mixed zucchini and squash (cut in 1/2 inch half-moon slices). For the HIGH-VOLUME PASTA (HVP) condition, participants view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) mixed with zucchini and squash (cut in 1/2 inch half-moon slices). For the LOW-VOLUME PASTA (LVP) condition, participants will view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) mixed with grated zucchini and squash (chopped in food processor). For the PASTA (P) condition, participants will view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) and no vegetables.

Behavioral: Eating

Meal Order 3

EXPERIMENTAL

\[HVP,LVP,P,P+S\] For the HIGH-VOLUME PASTA (HVP) condition, participants view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) mixed with zucchini and squash (cut in 1/2 inch half-moon slices). For the LOW-VOLUME PASTA (LVP) condition, participants will view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) mixed with grated zucchini and squash (chopped in food processor). For the PASTA (P) condition, participants will view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) and no vegetables. For the PASTA+SIDE (P+S) condition, participants will view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) with a side of mixed zucchini and squash (cut in 1/2 inch half-moon slices).

Behavioral: Eating

Meal Order 4

EXPERIMENTAL

\[LVP,P,P+S,HVP\] For the LOW-VOLUME PASTA (LVP) condition, participants will view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) mixed with grated zucchini and squash (chopped in food processor). For the PASTA (P) condition, participants will view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) and no vegetables. For the PASTA+SIDE (P+S) condition, participants will view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) with a side of mixed zucchini and squash (cut in 1/2 inch half-moon slices). For the HIGH-VOLUME PASTA (HVP) condition, participants view, consume, and evaluate a main pasta entree (Fettuccini Alfredo) mixed with zucchini and squash (cut in 1/2 inch half-moon slices).

Behavioral: Eating

Interventions

EatingBEHAVIORAL

Participants will have 20 minutes to eat as much or as little of a meal (consisting of pasta alone or pasta with zucchini and squash presented in 3 different ways)

Meal Order 1Meal Order 2Meal Order 3Meal Order 4

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) between 18.5 to 24.9 kg/m\^2
  • Unrestrained eater (\<12 on Three Factor Eating Questionnaire \[TFEQ\])
  • Report liking Fettucini Alfredo, zucchini, and squash (rate all items \>50mm on a visual analogue scale \[VAS\])
  • Report regularly eating before 10 am
  • Can compete all sessions within 8 weeks of the screening session

You may not qualify if:

  • Report binge eating
  • Report a medical condition that influences eating
  • Report allergies to foods used in the investigation
  • Currently smoke
  • Report dietary restrictions
  • Report taking a medication that affects appetite
  • Report being pregnant or breast-feeding
  • Report being an athlete in training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Laboratory, University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Related Publications (5)

  • Rolls BJ, Drewnowski A, Ledikwe JH. Changing the energy density of the diet as a strategy for weight management. J Am Diet Assoc. 2005 May;105(5 Suppl 1):S98-103. doi: 10.1016/j.jada.2005.02.033.

    PMID: 15867904BACKGROUND

  • Rolls BJ. The relationship between dietary energy density and energy intake. Physiol Behav. 2009 Jul 14;97(5):609-15. doi: 10.1016/j.physbeh.2009.03.011. Epub 2009 Mar 20.

    PMID: 19303887BACKGROUND

  • Rolls BJ, Meengs JS, Roe LS. Variations in cereal volume affect the amount selected and eaten for breakfast. J Acad Nutr Diet. 2014 Sep;114(9):1411-6. doi: 10.1016/j.jand.2014.01.014. Epub 2014 Mar 19.

    PMID: 24656953BACKGROUND

  • Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.

    PMID: 3981480BACKGROUND

  • Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.

    BACKGROUND

MeSH Terms

Interventions

Eating

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 22, 2015

Study Start

July 1, 2015

Primary Completion

December 31, 2021

Study Completion

December 31, 2025

Last Updated

April 3, 2025

Record last verified: 2025-04

Locations

US(1)