Body Weight DecreasedPhase 3NCT01659450
Low Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease
A Phase 3 study testing low energy dense and diet in people with Body Weight Decreased, run by Isfahan University of Medical Sciences.
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 . Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Decreased
- What is being tested?
- low energy dense and diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Nov 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- dietary poor compliance
About this study
Official title: 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 .
Read the 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.
- Conditions
- Body Weight Decreased
- Being tested
- low energy dense, control, diet
- Keywords
- overweight, obesity, low energy dense
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low energy denseOther
Also called LED
This group received a diet appropriate with their weight in the form of low energy density diet
controlOther
Also called usual
This group received a diet appropriate with their weight in the form of an usual diet regarding the energy density.
dietOther
Also called low energy dense, control
Calorie requirements of each subject were estimated based on resting energy expenditure (by the use of Harris-Benedict equation) and physical activity levels.
| Study group | Role | What they receive |
|---|---|---|
| Low energy dense | Experimental | 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 Receives: Other: low energy dense; Other: diet |
| control | Experimental | In the group with a control diet, 35% of the energy was provided by fat, 15% by protein and 50% by carbohydrate Receives: Other: control; Other: diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
better weight maintenance by LED
Measured: 7 months
Secondary outcomes (1)
better CVD risks status by LED
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Weight DecreasedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Azadbakht, Isfahan University of Medical Sciences
- Investigators
- Leila Azadbakht, PhD, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659450
- Sponsor's protocol ID
- Low energy density diet
- Other IDs
- IUMS
- Status last verified
- Aug 2012
- First submitted
- 1 Aug 2012
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
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(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PubMed 33512717
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Energy Density Diet and Weight Loss Maintenance
- ClinicalTrials.gov ID
- NCT01659450
- Acronym / sponsor ID
- Low energy density diet
- Conditions
- Body Weight Decreased
- Keywords
- overweight, obesity, low energy dense
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low energy dense | Experimental | Other: low energy dense, Other: dietDiet 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 | Experimental | Other: control, Other: dietIn the group with a control diet, 35% of the energy was provided by fat, 15% by protein and 50% by carbohydrate |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- dietary poor compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low energy denseAlso: LEDThis group received a diet appropriate with their weight in the form of low energy density diet | Other | Low energy dense |
| controlAlso: usualThis group received a diet appropriate with their weight in the form of an usual diet regarding the energy density. | Other | control |
| dietAlso: low energy dense, controlCalorie requirements of each subject were estimated based on resting energy expenditure (by the use of Harris-Benedict equation) and physical activity levels. | Other | Low energy dense, control |
Primary outcome
better weight maintenance by LED
Time frame: 7 months
1 secondary outcome
better CVD risks status by LED
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
- Derived from this study: PubMed 33512717Allaf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leila Azadbakht, PhD principal investigator
Isfahan University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing low energy dense and diet in people with Body Weight Decreased, run by Isfahan University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
better weight maintenance by LED (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01659450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2012.