Metabolic SyndromeNCT00673023
Study the Role of Genetic Variation in the Determining Lipid Profile Response to Dietary Change
A study testing Dietary experiments in people with Metabolic Syndrome, run by Tabriz University.
Trial summary
The purpose of this study is to determine whether plasma lipoproteins and lipid responsiveness to a dietary modification is influenced by CETP gene polymorphism. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Dietary experiments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Dec 2007
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy Volunteers
Who cannot join
- History of any cardiovascular diseases
- type 1 diabetes
- type 2 diabetes
- use of lipid-lowering medications
- hypertension
- pregnancy
- Current intake of vitamins and supplements
- History of endocrin disorder
About this study
Official title: Study the Role of Polymorphism at the CETP Gene Locuse in the Determining Lipid Profile Response to Dietary Change
The purpose of this study is to determine whether plasma lipoproteins and lipid responsiveness to a dietary modification is influenced by CETP gene polymorphism.
- Conditions
- Metabolic Syndrome
- Being tested
- Dietary experiments
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary experimentsOther
Dietary Supplement: high PUFA diet followed by high SFA diet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: Dietary experiments |
| 2 | Experimental | Not described Receives: Other: Dietary experiments |
| 3 | Experimental | Not described Receives: Other: Dietary experiments |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabriz University
- Sponsor type
- University, hospital or other
- Investigators
- Mohammad Noori, PhD, Study director, Tabriz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673023
- Sponsor's protocol ID
- 8641
- Status last verified
- May 2008
- First submitted
- 4 May 2008
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Role of Polymorphism at the CETP Gene Locuse in the Determining Lipid Profile Response to Dietary Change
- ClinicalTrials.gov ID
- NCT00673023
- Acronym / sponsor ID
- 8641
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Tabriz UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- First posted
- 7 May 2008 (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 purpose of this study is to determine whether plasma lipoproteins and lipid responsiveness to a dietary modification is influenced by CETP gene polymorphism.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Dietary experiments |
| 2 | Experimental | Other: Dietary experiments |
| 3 | Experimental | Other: Dietary experiments |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Volunteers
Key exclusion criteria (8 listed)
- History of any cardiovascular diseases
- type 1 diabetes
- type 2 diabetes
- use of lipid-lowering medications
- hypertension
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 |
|---|---|---|
| Dietary experimentsDietary Supplement: high PUFA diet followed by high SFA diet | Other | 1, 2, 3 |
Primary outcome
Not reported in the source record.
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 7 May 2008.
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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.
Mohammad Noori, PhD study director
Tabriz University
Questions about this trial
What is this clinical trial studying?
A study testing Dietary experiments in people with Metabolic Syndrome, run by Tabriz University.
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 1 inclusion and 8 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 7 May 2008. 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.
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.
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 7 May 2008.