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

History of Changes

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:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

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

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

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

Investigators

Principal Investigator:

Barbara J Rolls, PhD

The Pennsylvania State University

More Information

Additional Information:

Research lab at Penn State University This link exits the ClinicalTrials.gov site

Publications:

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.

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 Pt 2):98-103.

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. Review.

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.

Rolls BJ, Bell EA. Dietary approaches to the treatment of obesity. Med Clin North Am. 2000 Mar;84(2):401-18, vi. Review.

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.

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 May 16, 2013

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