Factors Affecting Caloric Regulation in Human Feeding

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT00108784
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

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

Study Timeline

• Study Start: 2003-03
• Study Completion: 2004-07
• Study First Submitted: 2005-04-18
• Study First Submitted QC: 2005-04-18
• Study First Posted: 2005-04-19
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight loss
Weight maintenance

Secondary Outcome Measures

Name	Time	Method
Changes in diet: quality and patterns, energy density, and fat content
Changes in lipids
Satisfaction with the two different dietary methods for weight loss

Trial Locations

Locations (1)

General Clinical Research Center: Penn State University; 🇺🇸 State College, Pennsylvania, United States