HypercholesteremiaNCT00153738
Phytosterol Supplementation and Cardiovascular Risk
A study testing phytosterol in people with Hypercholesteremia, run by The Cooper Institute at 1 site in United States.
Trial summary
This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12 weeks of supplementation. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesteremia
- What is being tested?
- phytosterol
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Aug 2005
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mild hypercholesteremia, sign informed consent, not donate blood, maintain diet and exercise habits
Who cannot join
- BMI <18.5 or >34.9, recent blood donation, serious or life-threatening disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk
This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12 weeks of supplementation.
Read the detailed description
This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12 weeks of supplementation.
The study recruited 72 men and women 20-70 years of age with mild hypercholesteremia (>130 mg/dl LDL-C). They were assigned to 1 of 2 groups. Participants ingested the supplement or a placebo for 12 weeks, with an interim assessment at 6 weeks. Participants agreed to maintain current diet, medication, and exercise habits and to not donate blood during the trial.
- Conditions
- Hypercholesteremia
- Being tested
- phytosterol
- Keywords
- LDL-C, phytosterol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phytosterolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ingestion of the supplement will result in reduced LDL cholesterol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesteremiaStudies 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
- Single group
- Masking
- Single blind
- Enrolment
- 72 participants
Sponsor and investigators
- Lead sponsor
- The Cooper Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cargill
- Investigators
- Conrad Earnest, PhD, Principal investigator, The Cooper Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153738
- Sponsor's protocol ID
- CI0129
- Status last verified
- Mar 2014
- First submitted
- 7 Sep 2005
- Last updated
- 13 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT00153738
- Acronym / sponsor ID
- CI0129
- Conditions
- Hypercholesteremia
- Keywords
- LDL-C, phytosterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants
- Lead sponsor
- The Cooper InstituteUniversity, hospital or other
- Collaborators
- Cargill
- Study start
- Mar 2004
- Study completion
- Aug 2005
- First posted
- 12 Sep 2005 (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.
This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12 weeks of supplementation.
Detailed description
This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12 weeks of supplementation.
The study recruited 72 men and women 20-70 years of age with mild hypercholesteremia (>130 mg/dl LDL-C). They were assigned to 1 of 2 groups. Participants ingested the supplement or a placebo for 12 weeks, with an interim assessment at 6 weeks. Participants agreed to maintain current diet, medication, and exercise habits and to not donate blood during the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mild hypercholesteremia, sign informed consent, not donate blood, maintain diet and exercise habits
Key exclusion criteria (1 listed)
- BMI <18.5 or >34.9, recent blood donation, serious or life-threatening disease
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 |
|---|---|---|
| phytosterol | Drug | – |
Primary outcome
Ingestion of the supplement will result in reduced LDL cholesterol.
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 13 Mar 2014.
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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.
Conrad Earnest, PhD principal investigator
The Cooper Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phytosterol in people with Hypercholesteremia, run by The Cooper Institute at 1 site in United States.
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 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 13 Mar 2014. 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 United States. 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?
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?
Ingestion of the supplement will result in reduced LDL cholesterol.. 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 13 Mar 2014.