Low Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease

Body Weight Decreased Clinical Trial

Official title:

Low Energy Density Diet and Weight Loss Maintenance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659450
• Other study ID #: Low energy density diet
• Secondary ID: IUMS
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2012
• Last updated: August 7, 2012
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: August 2012
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Body Weight
• Body Weight Decreased
• Weight Loss

Intervention

Other:
• low energy dense
This group received a diet appropriate with their weight in the form of low energy density diet
• control
This group received a diet appropriate with their weight in the form of an usual diet regarding the energy density.
• diet
Calorie requirements of each subject were estimated based on resting energy expenditure (by the use of Harris-Benedict equation) and physical activity levels.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	better weight control		7 months	Yes
Primary	better weight maintenance by LED		7 months	Yes
Secondary	better CVD risks status by LED		7 months	Yes