Low Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease
Low Energy Density Diet and Weight Loss Maintenance
2 other identifiers
interventional
35
0 countries
N/A
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2011
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 7, 2012
CompletedAugust 8, 2012
August 1, 2012
10 months
August 1, 2012
August 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
better weight maintenance by LED
7 months
Secondary Outcomes (1)
better CVD risks status by LED
7 months
Other Outcomes (1)
better weight control
7 months
Study Arms (2)
Low energy dense
EXPERIMENTALDiet 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
control
EXPERIMENTALIn the group with a control diet, 35% of the energy was provided by fat, 15% by protein and 50% by carbohydrate
Interventions
This group received a diet appropriate with their weight in the form of low energy density diet
This group received a diet appropriate with their weight in the form of an usual diet regarding the energy density.
Calorie requirements of each subject were estimated based on resting energy expenditure (by the use of Harris-Benedict equation) and physical activity levels.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- dietary poor compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 33512717DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leila Azadbakht, PhD
Isfahan University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 1, 2012
First Posted
August 7, 2012
Study Start
January 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
August 8, 2012
Record last verified: 2012-08