ObesityNCT00108784
Factors Affecting Caloric Regulation in Human Feeding
A study testing Reduced-energy-density diet in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Reduced-energy-density diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jul 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Heart disease
- Diabetes - type I or II
- High blood pressure
- Renal or kidney disease
- Gastrointestinal disease
- Blood clotting disorder
Show all 13Show fewer
- Liver disease or cirrhosis
- Any oral steroids
- Gout (requiring treatment)
- Anemia
- Lung disease
- Cancer within the last 5 years
- Thyroid disease
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center: Penn State University
State College, Pennsylvania, 16801
About this study
Official title: The Effect of Decreases in Energy Density on Weight Loss and Weight Maintenance
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.
Read the 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
- Being tested
- Reduced-energy-density diet
- Keywords
- reduced-energy-density diet, fat-restricted diet, fruit, vegetables, ad libitum intake, weight loss, obesity
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced-energy-density dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight maintenance
Secondary outcomes (3)
Changes in diet: quality and patterns, energy density, and fat content
Changes in lipids
Satisfaction with the two different dietary methods for weight loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2005 (estimated)
- Study startMar 2003
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Barbara J Rolls, PhD, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108784
- Sponsor's protocol ID
- FACTORS (completed)
- Other IDs
- R37DK039177
- Status last verified
- Jan 2010
- First submitted
- 18 Apr 2005
- Last updated
- 13 Jan 2010
- Results posted
- No
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.
PubMed 15867904Rolls 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.
PubMed 14995052Bell 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.
PubMed 11382653Rolls 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.
PubMed 10793649Rolls 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.
PubMed 10500012Ello-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.
PubMed 17556681
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Decreases in Energy Density on Weight Loss and Weight Maintenance
- ClinicalTrials.gov ID
- NCT00108784
- Acronym / sponsor ID
- FACTORS (completed)
- Conditions
- Obesity
- Keywords
- reduced-energy-density diet, fat-restricted diet, fruit, vegetables, ad libitum intake, weight loss, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Mar 2003
- Study completion
- Jul 2004
- First posted
- 19 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- Heart disease
- Diabetes - type I or II
- High blood pressure
- Renal or kidney disease
- Gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced-energy-density diet | Behavioural | – |
Primary outcome
Weight loss
Weight maintenance
3 secondary outcomes
Changes in diet: quality and patterns, energy density, and fat content
Changes in lipids
Satisfaction with the two different dietary methods for weight loss
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Background: PubMed 15867904Rolls 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.
- Background: PubMed 14995052Rolls 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.
- Background: PubMed 11382653Bell 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.
- Background: PubMed 10793649Rolls 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.
- Background: PubMed 10500012Rolls 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.
- Results publication: PubMed 17556681Ello-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara J Rolls, PhD principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced-energy-density diet in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00108784, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010; AzTrials last refreshed its copy on 6 Nov 2026.