Clinical trial NCT00108784: Factors Affecting Caloric Regulation in Human Feeding
Official title: The Effect of Decreases in Energy Density on Weight Loss and Weight Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: reduced-energy-density diet
fat-restricted diet
fruit
vegetables
ad libitum intake
weight loss
obesity
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2005-04-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Weight loss
measure: Weight maintenance
Secondary outcomes:
measure: Changes in diet: quality and patterns, energy density, and fat content
measure: Changes in lipids
measure: Satisfaction with the two different dietary methods for weight loss
Other outcomes:
Locations:
city: State College
country: United States
facility: General Clinical Research Center: Penn State University
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Barbara J Rolls, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rolls BJ, Drewnowski A, Ledikwe JH. Changing the energy density of the diet as a strategy for weight management. J Am Diet Assoc. 2005 May;105(5 Suppl 1):S98-103. doi: 10.1016/j.jada.2005.02.033.
citation: Rolls BJ, Ello-Martin JA, Tohill BC. What can intervention studies tell us about the relationship between fruit and vegetable consumption and weight management? Nutr Rev. 2004 Jan;62(1):1-17. doi: 10.1111/j.1753-4887.2004.tb00001.x.
citation: Bell EA, Rolls BJ. Energy density of foods affects energy intake across multiple levels of fat content in lean and obese women. Am J Clin Nutr. 2001 Jun;73(6):1010-8. doi: 10.1093/ajcn/73.6.1010.
citation: Rolls BJ, Bell EA. Dietary approaches to the treatment of obesity. Med Clin North Am. 2000 Mar;84(2):401-18, vi. doi: 10.1016/s0025-7125(05)70228-5.
citation: Rolls BJ, Bell EA, Thorwart ML. Water incorporated into a food but not served with a food decreases energy intake in lean women. Am J Clin Nutr. 1999 Oct;70(4):448-55. doi: 10.1093/ajcn/70.4.448.
citation: Ello-Martin JA, Roe LS, Ledikwe JH, Beach AM, Rolls BJ. Dietary energy density in the treatment of obesity: a year-long trial comparing 2 weight-loss diets. Am J Clin Nutr. 2007 Jun;85(6):1465-77. doi: 10.1093/ajcn/85.6.1465.