NCT00108784

Brief Summary

This study will test the hypothesis that reducing the energy density of the diet by incorporating more water-rich foods will result in: 1) greater weight loss and weight maintenance; 2) greater diet satisfaction and satiety; and 3) more healthful dietary patterns than reducing dietary fat alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2003

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, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2005

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

First QC Date

April 18, 2005

Last Update Submit

January 12, 2010

Conditions

Obesity

Keywords

reduced-energy-density dietfat-restricted dietfruitvegetablesad libitum intakeweight lossobesity

Outcome Measures

Primary Outcomes (2)

  • Weight loss

  • Weight maintenance

Secondary Outcomes (3)

  • Changes in diet: quality and patterns, energy density, and fat content

  • Changes in lipids

  • Satisfaction with the two different dietary methods for weight loss

Interventions

Reduced-energy-density dietBEHAVIORAL

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women
  • BMI (body mass index) 30 through 40 kg/m2
  • Normal blood pressure
  • LDL (low density lipoprotein)-cholesterol \< 90th percentile recommendations
  • Triglycerides, fasting blood glucose, and all other blood values within normal ranges
  • Able to participate in low to moderate physical activity.

You may not qualify if:

  • Heart disease
  • Diabetes - type I or II
  • High blood pressure
  • Renal or kidney disease
  • Gastrointestinal disease
  • Blood clotting disorder
  • Liver disease or cirrhosis
  • Any oral steroids
  • Gout (requiring treatment)
  • Anemia
  • Lung disease
  • Cancer within the last 5 years
  • Thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Clinical Research Center: Penn State University

State College, Pennsylvania, 16801, United States

Location

Related Publications (6)

  • 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, Ello-Martin JA, Tohill BC. What can intervention studies tell us about the relationship between fruit and vegetable consumption and weight management? Nutr Rev. 2004 Jan;62(1):1-17. doi: 10.1111/j.1753-4887.2004.tb00001.x.

    PMID: 14995052BACKGROUND

  • Bell EA, Rolls BJ. Energy density of foods affects energy intake across multiple levels of fat content in lean and obese women. Am J Clin Nutr. 2001 Jun;73(6):1010-8. doi: 10.1093/ajcn/73.6.1010.

    PMID: 11382653BACKGROUND

  • Rolls BJ, Bell EA. Dietary approaches to the treatment of obesity. Med Clin North Am. 2000 Mar;84(2):401-18, vi. doi: 10.1016/s0025-7125(05)70228-5.

    PMID: 10793649BACKGROUND

  • Rolls BJ, Bell EA, Thorwart ML. Water incorporated into a food but not served with a food decreases energy intake in lean women. Am J Clin Nutr. 1999 Oct;70(4):448-55. doi: 10.1093/ajcn/70.4.448.

    PMID: 10500012BACKGROUND

  • Ello-Martin JA, Roe LS, Ledikwe JH, Beach AM, Rolls BJ. Dietary energy density in the treatment of obesity: a year-long trial comparing 2 weight-loss diets. Am J Clin Nutr. 2007 Jun;85(6):1465-77. doi: 10.1093/ajcn/85.6.1465.

    PMID: 17556681RESULT

Related Links

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Barbara J Rolls, PhD

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 18, 2005

First Posted

April 19, 2005

Study Start

March 1, 2003

Study Completion

July 1, 2004

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations

US(1)