Body Mass Index Quantitative Trait Locus 7 DisorderPhase 3NCT01886482
Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children
A Phase 3 study testing nutrition intervention in people with Body Mass Index Quantitative Trait Locus 7 Disorder and Tangier Disease, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Mass Index Quantitative Trait Locus 7 Disorder, Tangier Disease
- What is being tested?
- nutrition intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Sep 2011to Sep 2012
- 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- BMI > 85th age of 6-11 years
- no history of chronic diseases
- no taken medications
Who cannot join
- do not prescribe their diet
- mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.
Read the detailed description
Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD) risk factors have reported contradictory results.
Objective: In present study, the investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.
Design: In this randomized controlled trial, the investigators recruited 50 overweight and obese women, aged 6-11years into HP or control energy restricted diets for 10 weeks (protein, carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount, divided to animal and plant sources in 50%-50% and animal sources distributed (half/half) between meats and dairy products. Fasting blood samples, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.
- Being tested
- nutrition intervention
- Medical subject headings
- Tangier Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition interventionOther
high protein diet
| Study group | Role | What they receive |
|---|---|---|
| nutrition intervention | Active comparator | high protein diet Receives: Other: nutrition intervention |
| no intervention | No intervention | control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of weight reduction in two dietary groups
weight reduction (kg)
Measured: 10 weeks
Secondary outcomes (5)
LDL (mg/ml)
Measured: 10 weeks
HDL (mg/ml)
Measured: 10 weeks
fasting blood glucose
Measured: 10 weeks
total cholesterol (mg/dl)
Measured: 10 weeks
blood pressure
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Mass Index Quantitative Trait Locus 7 DisorderStudies 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
- Participant
- Enrolment
- 50 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886482
- Sponsor's protocol ID
- high protein diet in childhood
- Status last verified
- Jun 2013
- First submitted
- 21 Jun 2013
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children
- ClinicalTrials.gov ID
- NCT01886482
- Acronym / sponsor ID
- high protein diet in childhood
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Jun 2013 (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.
The investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.
Detailed description
Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD) risk factors have reported contradictory results.
Objective: In present study, the investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.
Design: In this randomized controlled trial, the investigators recruited 50 overweight and obese women, aged 6-11years into HP or control energy restricted diets for 10 weeks (protein, carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount, divided to animal and plant sources in 50%-50% and animal sources distributed (half/half) between meats and dairy products. Fasting blood samples, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nutrition intervention | Active comparator | Other: nutrition interventionhigh protein diet |
| no intervention | No intervention | –control diet |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- BMI > 85th age of 6-11 years
- no history of chronic diseases
- no taken medications
Key exclusion criteria (2 listed)
- do not prescribe their diet
- mental retardation
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 |
|---|---|---|
| nutrition interventionhigh protein diet | Other | nutrition intervention |
Primary outcome
the amount of weight reduction in two dietary groups
Time frame: 10 weeks
weight reduction (kg)
5 secondary outcomes
LDL (mg/ml)
Time frame: 10 weeks
HDL (mg/ml)
Time frame: 10 weeks
fasting blood glucose
Time frame: 10 weeks
total cholesterol (mg/dl)
Time frame: 10 weeks
blood pressure
Time frame: 10 weeks
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 26 Jun 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nutrition intervention in people with Body Mass Index Quantitative Trait Locus 7 Disorder and Tangier Disease, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 2 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 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
the amount of weight reduction in two dietary groups (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2013.