PostmenopausalNCT00457262
Effects of Soy Protein on Serum paraoxonase1 Activity and Lipoproteins in Postmenopausal Women
A study testing soy consumption in people with Postmenopausal and Hyperlipidemia, run by Iran University of Medical Sciences.
Trial summary
paraoxonase 1 is involved to prevent LDL and HDL oxidation,so increase of it's activity leads to lower risk of coronary heart disease.In postmenopausal women ,we have decrease of paraoxonase1 activity and soy proteins may increase paraoxonase1 activity Read more about this study
- Who is it for?
- Ages 51 to 57 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal, Hyperlipidemia
- What is being tested?
- soy consumption
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Aug 2006
- 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 51 to 57 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cessation of menes for more than 1 year, elevation for more than 1 year
- Elevation of FSH level
- Total cholesterol
- Triglyceride more than 200 mg/dl
Who cannot join
- Chronic disease (heart disease, cancer, diabetes, hepatic, kidney and thyroid disease)
- Antihypertensive drugs
- Antibiotics
- Lipid lowering drugs
- Sex hormone treatment
- Hysterectomy
- Diet rich in soy protein
About this study
paraoxonase 1 is involved to prevent LDL and HDL oxidation,so increase of it's activity leads to lower risk of coronary heart disease.In postmenopausal women ,we have decrease of paraoxonase1 activity and soy proteins may increase paraoxonase1 activity
Read the detailed description
In a double blind clinical randomised clinical trial with parallel design this study was done.52 postmenopausal women were randomly assigned to 50 g/d soy protein or placebo for 10 weeks.serum lipoproteins and pon1 activity were measured at baseline and 10th week.There were significant increase in PON! activity and significant decrease in LDL-C,LDL-C/HDL-C,TC/HDL-C and TG/HDL-C in soy group compare to placebo group.
- Conditions
- Postmenopausal, Hyperlipidemia
- Being tested
- soy consumption
- Keywords
- paraoxonase1 activity, LDL, HDL, postmenopausal women, postmenopausal women and hyperlipidemia
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy consumptionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease of LDL,increase of HDL,increase of paraoxonase 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startJan 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopausalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- farzad Shidfar, Ph.D, Study chair, assistant professor of nutrition,Iran university of medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457262
- Sponsor's protocol ID
- 1344
- Status last verified
- Mar 2007
- First submitted
- 4 Apr 2007
- Last updated
- 6 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Soy Protein on Serum paraoxonase1 Activity and Lipoproteins in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00457262
- Acronym / sponsor ID
- 1344
- Conditions
- Postmenopausal, Hyperlipidemia
- Keywords
- paraoxonase1 activity, LDL, HDL, postmenopausal women, postmenopausal women and hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Aug 2006 (actual)
- First posted
- 6 Apr 2007 (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.
paraoxonase 1 is involved to prevent LDL and HDL oxidation,so increase of it's activity leads to lower risk of coronary heart disease.In postmenopausal women ,we have decrease of paraoxonase1 activity and soy proteins may increase paraoxonase1 activity
Detailed description
In a double blind clinical randomised clinical trial with parallel design this study was done.52 postmenopausal women were randomly assigned to 50 g/d soy protein or placebo for 10 weeks.serum lipoproteins and pon1 activity were measured at baseline and 10th week.There were significant increase in PON! activity and significant decrease in LDL-C,LDL-C/HDL-C,TC/HDL-C and TG/HDL-C in soy group compare to placebo group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 51 to 57 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Cessation of menes for more than 1 year, elevation for more than 1 year
- Elevation of FSH level
- Total cholesterol
- Triglyceride more than 200 mg/dl
Key exclusion criteria (7 listed)
- Chronic disease (heart disease, cancer, diabetes, hepatic, kidney and thyroid disease)
- Antihypertensive drugs
- Antibiotics
- Lipid lowering drugs
- Sex hormone treatment
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 |
|---|---|---|
| soy consumption | Procedure or surgery | – |
Primary outcome
decrease of LDL,increase of HDL,increase of paraoxonase 1
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 6 Apr 2007.
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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.
farzad Shidfar, Ph.D study chair
assistant professor of nutrition,Iran university of medical sciences
Questions about this trial
What is this clinical trial studying?
A study testing soy consumption in people with Postmenopausal and Hyperlipidemia, run by Iran 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 4 inclusion and 7 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 6 Apr 2007. 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.
What does the primary outcome measure?
decrease of LDL,increase of HDL,increase of paraoxonase 1. 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 6 Apr 2007.