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Factors Affecting Caloric Regulation in Human Feeding

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status

Completed

Conditions

Obesity

Treatments

Behavioral: Reduced-energy-density diet

Study type

Interventional

Funder types

NIH

Identifiers

NCT00108784
FACTORS (completed)
R37DK039177 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Sex

Female

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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