HyperlipidemiasNCT01600313
Effect of Low Calorie Diet With Rice Bran Oil on Cardiovascular Risk Factors in Hyperlipidemic Patients
A study testing rice bran oil in people with Hyperlipidemias, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine the effect of rice bran oil with low calorie diet on lipid profiles. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- rice bran oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Jun 2008to Jun 2012
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hyperlipidemia
Who cannot join
- pregnancy and lactation
- cardiovascular disease
- diabetes
Trial locations and contacts
1 site in 1 country.
Iran1 site
Qazvin University of Medical Sciences
Qazvin, Qazvin Province, 34197-59811
About this study
The purpose of this study is to determine the effect of rice bran oil with low calorie diet on lipid profiles.
Read the detailed description
This study is parallel groups' randomized clinical trial with a pre and post test design.
The study conducted on hyperglycemia patients who were healthy in other respects and were recruited from nutrition and diet therapy clinic. All subjects received a low calorie diet for 4 weeks from registered dietitian.
Treatment group received the low- calorie diet including (30g/day) rice bran oil.
- Conditions
- Hyperlipidemias
- Being tested
- rice bran oil
- Keywords
- rice bran oil, diet, cardiovascular disease, low density lipoprotein, total cholesterol
- Medical subject headings
- Hyperlipidemias, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rice bran oilDietary supplement
Also called King rice bran oil, Bangkok, Thailand)
Treatment group received the low - calorie diet with(30g/day) rice bran oil
| Study group | Role | What they receive |
|---|---|---|
| treatment, control | Experimental | Not described Receives: Dietary Supplement: rice bran oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL, HDL, Cholesterol,Triglyceride(mg/dl)
enzymatic reagents
Measured: 30 days
Secondary outcomes (2)
BMI (Kg/m2)
weight/(height)2
Measured: Baseline and 4 weeks after intervention
WHR (Ratio)
Waist(Cm)/Hip(Cm)
Measured: Baseline and 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startJun 2008
- Primary completionMay 2010
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mostafa Noroozi, Qazvin University Of Medical Sciences
- Investigators
- Mostafa Noroozi, PhD, Principal investigator, Qazvin University of Medical Sceience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600313
- Sponsor's protocol ID
- QUMS-2225
- Status last verified
- May 2012
- First submitted
- 10 May 2012
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Calorie Diet With Rice Bran Oil on Cardiovascular Risk Factors in Hyperlipidemic Patients
- ClinicalTrials.gov ID
- NCT01600313
- Acronym / sponsor ID
- QUMS-2225
- Conditions
- Hyperlipidemias
- Keywords
- rice bran oil, diet, cardiovascular disease, low density lipoprotein, total cholesterol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2012 (estimated)
- First posted
- 17 May 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.
The purpose of this study is to determine the effect of rice bran oil with low calorie diet on lipid profiles.
Detailed description
This study is parallel groups' randomized clinical trial with a pre and post test design.
The study conducted on hyperglycemia patients who were healthy in other respects and were recruited from nutrition and diet therapy clinic. All subjects received a low calorie diet for 4 weeks from registered dietitian.
Treatment group received the low- calorie diet including (30g/day) rice bran oil.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment, control | Experimental | Dietary Supplement: rice bran oil |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hyperlipidemia
Key exclusion criteria (3 listed)
- pregnancy and lactation
- cardiovascular disease
- diabetes
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 |
|---|---|---|
| rice bran oilAlso: King rice bran oil, Bangkok, Thailand)Treatment group received the low - calorie diet with(30g/day) rice bran oil | Dietary supplement | treatment, control |
Primary outcome
LDL, HDL, Cholesterol,Triglyceride(mg/dl)
Time frame: 30 days
enzymatic reagents
2 secondary outcomes
BMI (Kg/m2)
Time frame: Baseline and 4 weeks after intervention
WHR (Ratio)
Time frame: Baseline and 4 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2012.
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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.
Mostafa Noroozi, PhD principal investigator
Qazvin University of Medical Sceience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rice bran oil in people with Hyperlipidemias, run by Qazvin 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 May 2012. 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.
Are results available for this study?
Results are not available in the source record.
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?
LDL, HDL, Cholesterol,Triglyceride(mg/dl) (time frame: 30 days). 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 17 May 2012.