Factors Affecting Caloric Regulation in Human Feeding

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00108784
First received: April 18, 2005
Last updated: January 12, 2010
Last verified: January 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Ages Eligible for Study:   20 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108784

Locations
United States, Pennsylvania
General Clinical Research Center: Penn State University
State College, Pennsylvania, United States, 16801
Sponsors and Collaborators
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), R37DK 039177
Study First Received: April 18, 2005
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014