- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00108784
Factors Affecting Caloric Regulation in Human Feeding
The Effect of Decreases in Energy Density on Weight Loss and Weight Maintenance
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
State College, Pennsylvania, United States, 16801
- General Clinical Research Center: Penn State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Weight loss
|
Weight maintenance
|
Secondary Outcome Measures
Outcome Measure |
---|
Changes in diet: quality and patterns, energy density, and fat content
|
Changes in lipids
|
Satisfaction with the two different dietary methods for weight loss
|
Collaborators and Investigators
Investigators
- Principal Investigator: Barbara J Rolls, PhD, The Pennsylvania State University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FACTORS (completed)
- R37DK039177 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Reduced-energy-density diet
-
Hacettepe UniversityEnrolling by invitationPolycystic Ovary Syndrome | Diet HabitTurkey
-
Texas Tech UniversityCompleted
-
Pennington Biomedical Research CenterNational Institute on Aging (NIA)RecruitingInsulin Sensitivity | ApathyUnited States
-
University of Alabama at BirminghamMedifast, Inc.CompletedObesity | Nutrition Disorders | Overweight | Body Weight | Weight LossUnited States
-
Carol Fabian, MDCompletedBreast Cancer FemaleUnited States
-
IMDEA FoodMinisterio de Ciencia e Innovación, Spain; CIBER Fisiopatología de la Obesidad...Recruiting
-
University of California, DavisCompleted
-
Drexel UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Pennington Biomedical Research CenterAlliance for Potato Research and EducationCompleted
-
Norwegian University of Science and TechnologyMonash University; Portuguese Research CouncilCompleted