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Low Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease

NCT ID: NCT01659450

Last Updated: 2012-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Body Weight Decreased

Keywords

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overweight obesity low energy dense

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

low energy dense

Intervention Type OTHER

This group received a diet appropriate with their weight in the form of low energy density diet

diet

Intervention Type OTHER

Calorie requirements of each subject were estimated based on resting energy expenditure (by the use of Harris-Benedict equation) and physical activity levels.

control

In the group with a control diet, 35% of the energy was provided by fat, 15% by protein and 50% by carbohydrate

Group Type EXPERIMENTAL

control

Intervention Type OTHER

This group received a diet appropriate with their weight in the form of an usual diet regarding the energy density.

diet

Intervention Type OTHER

Calorie requirements of each subject were estimated based on resting energy expenditure (by the use of Harris-Benedict equation) and physical activity levels.

Interventions

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low energy dense

This group received a diet appropriate with their weight in the form of low energy density diet

Intervention Type OTHER

control

This group received a diet appropriate with their weight in the form of an usual diet regarding the energy density.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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LED usual low energy dense control

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Leila Azadbakht

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leila Azadbakht, PhD

Role: PRINCIPAL_INVESTIGATOR

Isfahan University of Medical Sciences

References

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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.

Reference Type DERIVED
PMID: 33512717 (View on PubMed)

Other Identifiers

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IUMS

Identifier Type: OTHER

Identifier Source: secondary_id

Low energy density diet

Identifier Type: -

Identifier Source: org_study_id