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Factors Affecting Caloric Regulation in Human Feeding

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00108784
First Posted: April 19, 2005
Last Update Posted: January 13, 2010
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.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
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.

Condition Intervention
Obesity Behavioral: Reduced-energy-density diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Effect of Decreases in Energy Density on Weight Loss and Weight Maintenance

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Weight loss
  • Weight maintenance

Secondary Outcome Measures:
  • Changes in diet: quality and patterns, energy density, and fat content
  • Changes in lipids
  • Satisfaction with the two different dietary methods for weight loss

Estimated Enrollment: 100
Study Start Date: March 2003
Estimated Study Completion Date: July 2004
Detailed Description:

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108784


Locations
United States, Pennsylvania
General Clinical Research Center: Penn State University
State College, Pennsylvania, United States, 16801
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Barbara J Rolls, PhD The Pennsylvania State University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00108784     History of Changes
Other Study ID Numbers: FACTORS (completed)
R37DK039177 ( U.S. NIH Grant/Contract )
First Submitted: April 18, 2005
First Posted: April 19, 2005
Last Update Posted: January 13, 2010
Last Verified: January 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
reduced-energy-density diet
fat-restricted diet
fruit
vegetables
ad libitum intake
weight loss
obesity