Back to resultsLow Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease
Primary Purpose
Body Weight Decreased
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
low energy dense
control
diet
Sponsored by
About this trial
This is an interventional health services research trial for Body Weight Decreased focused on measuring overweight, obesity, low energy dense
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low energy dense
control
Arm Description
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
In the group with a control diet, 35% of the energy was provided by fat, 15% by protein and 50% by carbohydrate
Outcomes
Primary Outcome Measures
better weight maintenance by LED
Secondary Outcome Measures
better CVD risks status by LED
Full Information
NCT ID
NCT01659450
First Posted
August 1, 2012
Last Updated
August 7, 2012
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01659450
Brief Title
Low Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease
Official Title
Low Energy Density Diet and Weight Loss Maintenance
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigators presumed that low energy density (LED) diet consumers will have lower risk of cardiovascular disease and are able to maintain their weight longer .
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Decreased
Keywords
overweight, obesity, low energy dense
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low energy dense
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
Experimental
Arm Description
In the group with a control diet, 35% of the energy was provided by fat, 15% by protein and 50% by carbohydrate
Intervention Type
Other
Intervention Name(s)
low energy dense
Other Intervention Name(s)
LED
Intervention Description
This group received a diet appropriate with their weight in the form of low energy density diet
Intervention Type
Other
Intervention Name(s)
control
Other Intervention Name(s)
usual
Intervention Description
This group received a diet appropriate with their weight in the form of an usual diet regarding the energy density.
Intervention Type
Other
Intervention Name(s)
diet
Other Intervention Name(s)
low energy dense, control
Intervention Description
Calorie requirements of each subject were estimated based on resting energy expenditure (by the use of Harris-Benedict equation) and physical activity levels.
Primary Outcome Measure Information:
Title
better weight maintenance by LED
Time Frame
7 months
Secondary Outcome Measure Information:
Title
better CVD risks status by LED
Time Frame
7 months
Other Pre-specified Outcome Measures:
Title
better weight control
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leila Azadbakht, PhD
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
33512717
Citation
Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
Results Reference
derived
Learn more about this trial
Low Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease
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