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Low Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01659450
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : August 8, 2012
Sponsor:
Information provided by (Responsible Party):
Leila Azadbakht, Isfahan University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE August 1, 2012
First Posted Date  ICMJE August 7, 2012
Last Update Posted Date August 8, 2012
Study Start Date  ICMJE January 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2012)
better weight maintenance by LED [ Time Frame: 7 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2012)
better weight maintence by LED [ Time Frame: 7 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2012)
better CVD risks status by LED [ Time Frame: 7 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 4, 2012)
better weight control [ Time Frame: 7 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Low Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease
Official Title  ICMJE Low Energy Density Diet and Weight Loss Maintenance
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Body Weight Decreased
Intervention  ICMJE
  • 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: 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Other: low energy dense
    • Other: diet
  • Experimental: control
    In the group with a control diet, 35% of the energy was provided by fat, 15% by protein and 50% by carbohydrate
    Interventions:
    • Other: control
    • Other: diet
Publications * 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:CD013496. doi: 10.1002/14651858.CD013496.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2012)
35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01659450
Other Study ID Numbers  ICMJE Low energy density diet
IUMS ( Other Identifier: Isfahan University of Medical Sciences )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Leila Azadbakht, Isfahan University of Medical Sciences
Original Responsible Party Leila Azadbakht, Isfahan University of Medical Sciences
Current Study Sponsor  ICMJE Isfahan University of Medical Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leila Azadbakht, PhD Isfahan University of Medical Sciences
PRS Account Isfahan University of Medical Sciences
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP