Low Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease

August 7, 2012 updated by: Leila Azadbakht, Isfahan University of Medical Sciences

Low Energy Density Diet and Weight Loss Maintenance

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

35

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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:
  • control
  • low energy dense
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: 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:
  • control
  • low energy dense
Other: control
This group received a diet appropriate with their weight in the form of an usual diet regarding the energy density.
Other Names:
  • usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
better weight maintenance by LED
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
better CVD risks status by LED
Time Frame: 7 months
7 months

Other Outcome Measures

Outcome Measure
Time Frame
better weight control
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

August 1, 2012

First Submitted That Met QC Criteria

August 4, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Low energy density diet
  • IUMS (Isfahan University of Medical Sciences)

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.

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