Factors Affecting Caloric Regulation in Human Feeding

NCT ID: NCT00108784

Last Updated: 2010-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2004-07-31

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

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Reduced-energy-density diet

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: lead

Principal Investigators

Barbara J Rolls, PhD

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Locations

General Clinical Research Center: Penn State University

State College, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15867904 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14995052 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11382653 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10793649 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10500012 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17556681 (View on PubMed)

Related Links

http://nutrition.hhdev.psu.edu/foodlab/

Research lab at Penn State University

Other Identifiers

R37DK039177

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FACTORS (completed)

Identifier Type: -

Identifier Source: org_study_id