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Factors Affecting Caloric Regulation in Human Feeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00108784
Recruitment Status : Completed
First Posted : April 19, 2005
Last Update Posted : January 13, 2010
Information provided by:

April 18, 2005
April 19, 2005
January 13, 2010
March 2003
Not Provided
  • Weight loss
  • Weight maintenance
Same as current
Complete list of historical versions of study NCT00108784 on ClinicalTrials.gov Archive Site
  • Changes in diet: quality and patterns, energy density, and fat content
  • Changes in lipids
  • Satisfaction with the two different dietary methods for weight loss
Same as current
Not Provided
Not Provided
Factors Affecting Caloric Regulation in Human Feeding
The Effect of Decreases in Energy Density on Weight Loss and Weight Maintenance
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.

Energy density refers to the amount of calories (energy) in a given weight of food. For the same amount of energy, a larger volume (weight) of food can be consumed if the food or diet is low in energy density than if the food or diet is high in energy density. The two nutrients that have the largest impact on energy density are fat and water. Foods high in fat and low in water content are typically high in energy density, whereas foods low in fat and high in water content, such as fruits and vegetables, are low in energy density. This study will examine whether there are increased benefits for weight loss and weight maintenance when the ad libitum consumption of water-rich foods is added to a reduced-fat diet, thus making it even lower in energy density.

Comparisons: Reduced-energy-dense diet and Reduced-fat diet

Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Behavioral: Reduced-energy-density diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2004
Not Provided

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sexes Eligible for Study: Female
20 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
FACTORS (completed)
R37DK039177 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Barbara J Rolls, PhD The Pennsylvania State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP