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Low Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leila Azadbakht, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01659450
First received: August 1, 2012
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

Investigators presumed that low energy density (LED) diet consumers will have lower risk of cardiovascular disease and are able to maintain their weight longer .


Condition Intervention Phase
Body Weight Decreased
 Other: low energy dense
Other: control
Other: diet
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Low Energy Density Diet and Weight Loss Maintenance

Resource links provided by NLM:

MedlinePlus related topics: Weight Control
U.S. FDA Resources

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • better weight maintenance by LED [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • better CVD risks status by LED [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • better weight control [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low energy dense
Diet of the LED group contained 30%fat, 15% protein and 55% carbohydrate. Most of the consumed carbohydrates in the LED diet group were fruits, vegetables and whole grains. In addition, this group received more servings of vegetables groups daily in the form of liquid diets or some menus contain more vegetables
 Other: low energy dense
This group received a diet appropriate with their weight in the form of low energy density diet
Other Name: LED
Other: diet
Calorie requirements of each subject were estimated based on resting energy expenditure (by the use of Harris-Benedict equation) and physical activity levels.
Other Names:
  • low energy dense
  • control
Experimental: control
In the group with a control diet, 35% of the energy was provided by fat, 15% by protein and 50% by carbohydrate
 Other: control
This group received a diet appropriate with their weight in the form of an usual diet regarding the energy density.
Other Name: usual
Other: diet
Calorie requirements of each subject were estimated based on resting energy expenditure (by the use of Harris-Benedict equation) and physical activity levels.
Other Names:
  • low energy dense
  • control

Detailed Description:

Previous studies introduced different dietary interventions for weight loss maintenance. Besides the debate on low fat or low carbohydrate diets, focusing on some food groups including fruits, vegetables and low fat dairies in the diet may be helpful for weight maintenance. However, energy intake is the key factor of weight maintenance. Energy intake will decrease by reducing energy density (ED) of a diet without producing short-term calorie restriction or feeling hunger. There are several studies which showed the beneficial effects of low energy density diets on weight reduction. However, few studies discuses regarding the effects of such diets on weight maintenance.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • who were on weight loss diet for the last one year and additionally, they did not want to lose more weight.
  • Non-pregnant, non-lactaries and non-smokers aged 40-70 years included in the present study

Exclusion Criteria:

  • dietary poor compliance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659450

Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: Leila Azadbakht, PhD Isfahan University of Medical Sciences
  More Information

No publications provided

Responsible Party: Leila Azadbakht, Principal Investigator, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01659450     History of Changes
Other Study ID Numbers: Low energy density diet, IUMS
Study First Received: August 1, 2012
Last Updated: August 7, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Isfahan University of Medical Sciences:
overweight
obesity
low energy dense

Additional relevant MeSH terms:
Body Weight
Cardiovascular Diseases
Weight Loss
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on June 17, 2013