NCT01470300

Brief Summary

The purpose of this research is to investigate how using different methods to reduce the energy density of entrees affects daily energy intake in adults. It is hypothesized that reducing the energy density of entrees will decrease energy intake. It is also hypothesized that reducing the energy density by incorporating fruit and vegetables will decrease energy intake more than reducing the energy density by decreasing fat content or adding plain water.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
Last Updated

November 11, 2011

Status Verified

November 1, 2011

Enrollment Period

8 months

First QC Date

November 9, 2011

Last Update Submit

November 10, 2011

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Energy intake

    1 month

Secondary Outcomes (1)

  • Food intake

    1 month

Study Arms (4)

Standard ED

EXPERIMENTAL

100% energy density

Other: Energy density feeding study

Reduced ED - F/V

EXPERIMENTAL

80% energy density by adding fruit and vegetables

Other: Energy density feeding study

Reduced ED - Fat

EXPERIMENTAL

80% energy density by decreasing fat

Other: Energy density feeding study

Reduced ED - Plain water

EXPERIMENTAL

80% energy density by adding plain water

Other: Energy density feeding study

Interventions

Energy density feeding studyOTHER

In a crossover design, adults are served breakfast, lunch, and dinner, 1 day a week for 4 weeks. Meal entrees will vary in energy density (100% and 80%) and the method used to reduce the energy density (added fruit \& vegetables, decreased fat, added plain water).

Reduced ED - F/VReduced ED - FatReduced ED - Plain waterStandard ED

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults from Penn State and surrounding community

You may not qualify if:

  • Currently dieting
  • Food allergies

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

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Barbara J Rolls

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 11, 2011

Study Start

September 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

November 11, 2011

Record last verified: 2011-11

Locations

US(1)