NCT01165086

Brief Summary

This study will test the hypothesis that incorporating vegetables into meals as a method of reducing the energy density will result in increased vegetable intake and decreased energy intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2009

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

November 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 10, 2011

Status Verified

November 1, 2011

Enrollment Period

1.1 years

First QC Date

July 16, 2010

Last Update Submit

November 9, 2011

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Energy intake

    3 weeks

Secondary Outcomes (1)

  • Vegetable intake

    3 weeks

Interventions

Incorporating vegetables into the diet to reduce energy densityOTHER

The entree portion of breakfast, lunch, and dinner meals will be manipulated to be a standard energy density, a 15% reduction in energy density, or a 25% reduction in energy density.

Eligibility Criteria

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

You may qualify if:

  • Healthy adults aged 20-45 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

  • Blatt AD, Roe LS, Rolls BJ. Hidden vegetables: an effective strategy to reduce energy intake and increase vegetable intake in adults. Am J Clin Nutr. 2011 Apr;93(4):756-63. doi: 10.3945/ajcn.110.009332. Epub 2011 Feb 2.

    PMID: 21289225DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 19, 2010

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

November 10, 2011

Record last verified: 2011-11

Locations

US(1)