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OpenTrials
Completed

NCT Number: NCT00108784

Factors Affecting Caloric Regulation in Human Feeding

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.

Completed

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Key information

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

General Clinical Research Center: Penn State University

State College, Pennsylvania, 16801, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reduced-energy-density diet

Behavioral

Primary outcomes

  1. Weight loss

  2. Weight maintenance

Secondary outcomes

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

  2. Changes in lipids

  3. Satisfaction with the two different dietary methods for weight loss

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Official study title

The Effect of Decreases in Energy Density on Weight Loss and Weight Maintenance

Important dates

Study start
2003
Study completion
2004
First posted
Apr 19, 2005
Registry last updated
Jan 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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