Hypercholesterolemiaphyteaux-INCT00860054
Addition of Phytosterols to a Low Phytosterol Diet
A study testing Different amount of phytosterols are added into diets in people with Hypercholesterolemia and Coronary Heart Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Studies have shown that phytosterols will lower LDL cholesterol. Typical diets can contain between 250 to 500 mg of naturally-occurring phytosterols. Long-term studies with phytosterol-containing products(such as margarines) have not taken into account the amounts of naturally occurring phytosterols in the diet. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Coronary Heart Disease
- What is being tested?
- Different amount of phytosterols are added into diets
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Oct 2008
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women are eligible who:
- are of any race or ethnicity between 18 to 80 years of age;
- are in generally good health;
- have moderately elevated blood cholesterol(LDL cholesterol between 100 and 189 mg/dl)
- will eat only the foods that are provided by the center during the diet periods;
- will drink no more than 5 cups of caffeine-containing beverages a day;
- will consume no more than 1 alcoholic drink a day;
- will abstain from the consumption of alcohol for 48-hours prior to blood draw days
Who cannot join
- are younger than 18 or older than 80 years;
- have very high cholesterol(LDL cholesterol equal to or above 190 mg/dl or triglycerides equal to or above 250 mg/dl);
- have very high blood pressure(equal to or above 160 mm Hg systolic or 95 mm Hg diastolic);
- are overweight( BMI greater than 35 kg/m2)
- are taking lipid-lowering, or any other medication known to affect blood cholesterol;
- have diabetes mellitus, cancer, heart, liver and/or kidney disease, or chronic disease that might interfere with participation;
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Regulation of Cholesterol Absorption: Dose Response of LDL to Phytosterols Added to a Phytosterol-Poor Diet
Studies have shown that phytosterols will lower LDL cholesterol. Typical diets can contain between 250 to 500 mg of naturally-occurring phytosterols. Long-term studies with phytosterol-containing products(such as margarines) have not taken into account the amounts of naturally occurring phytosterols in the diet. This means that the effects of small amounts of natural dietary phytosterols on LDL cholesterol are not known. In this study, we will examine the effects of phytosterols across a range of levels. The information will likely be used to further support and possibly extend the current dietary recommendations for phytosterol use.
- Conditions
- Hypercholesterolemia, Coronary Heart Disease
- Being tested
- Different amount of phytosterols are added into diets
- Keywords
- phytosterols, cholesterol excretion, cholesterol absorption, diet, mass spectrometry, deuterium
- Medical subject headings
- Hypercholesterolemia, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different amount of phytosterols are added into dietsDietary supplement
Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.
| Study group | Role | What they receive |
|---|---|---|
| Medium Phytosterols | Experimental | Diets with daily 400 mg of phytosterols Receives: Dietary Supplement: Different amount of phytosterols are added into diets |
| High Phytosterols Diet | Experimental | Diet with 2000 mg of daily phytosterols Receives: Dietary Supplement: Different amount of phytosterols are added into diets |
| Low Phyto Diet | Placebo comparator | Diet with less than 100 mg of daily phytosterols Receives: Dietary Supplement: Different amount of phytosterols are added into diets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal cholesterol excretion
Measured: At the end of week 4 on each diet
Secondary outcomes (1)
intestinal cholesterol absorption
Measured: At the end of week 4 on each diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startMar 2006
- Primary completionSep 2006
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Principal investigator, Richard E. Ostlund Jr., MD, Washington University School of Medicine
- Investigators
- Richard Ostlund, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860054
- Sponsor's protocol ID
- PBRC25025
- Other IDs
- R01HL050420
- Acronym
- phyteaux-I
- Status last verified
- Apr 2012
- First submitted
- 10 Mar 2009
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Racette SB, Lin X, Lefevre M, Spearie CA, Most MM, Ma L, Ostlund RE Jr. Dose effects of dietary phytosterols on cholesterol metabolism: a controlled feeding study. Am J Clin Nutr. 2010 Jan;91(1):32-8. doi: 10.3945/ajcn.2009.28070. Epub 2009 Nov 4.
PubMed 19889819
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Cholesterol Absorption: Dose Response of LDL to Phytosterols Added to a Phytosterol-Poor Diet
- ClinicalTrials.gov ID
- NCT00860054
- Acronym / sponsor ID
- phyteaux-I / PBRC25025
- Conditions
- Hypercholesterolemia, Coronary Heart Disease
- Keywords
- phytosterols, cholesterol excretion, cholesterol absorption, diet, mass spectrometry, deuterium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Study start
- Mar 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 11 Mar 2009 (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.
Studies have shown that phytosterols will lower LDL cholesterol. Typical diets can contain between 250 to 500 mg of naturally-occurring phytosterols. Long-term studies with phytosterol-containing products(such as margarines) have not taken into account the amounts of naturally occurring phytosterols in the diet. This means that the effects of small amounts of natural dietary phytosterols on LDL cholesterol are not known. In this study, we will examine the effects of phytosterols across a range of levels. The information will likely be used to further support and possibly extend the current dietary recommendations for phytosterol use.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medium Phytosterols | Experimental | Dietary Supplement: Different amount of phytosterols are added into dietsDiets with daily 400 mg of phytosterols |
| High Phytosterols Diet | Experimental | Dietary Supplement: Different amount of phytosterols are added into dietsDiet with 2000 mg of daily phytosterols |
| Low Phyto Diet | Placebo comparator | Dietary Supplement: Different amount of phytosterols are added into dietsDiet with less than 100 mg of daily phytosterols |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- are of any race or ethnicity between 18 to 80 years of age;
- are in generally good health;
- have moderately elevated blood cholesterol(LDL cholesterol between 100 and 189 mg/dl)
- will eat only the foods that are provided by the center during the diet periods;
- will drink no more than 5 cups of caffeine-containing beverages a day;
Key exclusion criteria (6 listed)
- are younger than 18 or older than 80 years;
- have very high cholesterol(LDL cholesterol equal to or above 190 mg/dl or triglycerides equal to or above 250 mg/dl);
- have very high blood pressure(equal to or above 160 mm Hg systolic or 95 mm Hg diastolic);
- are overweight( BMI greater than 35 kg/m2)
- are taking lipid-lowering, or any other medication known to affect blood cholesterol;
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 |
|---|---|---|
| Different amount of phytosterols are added into dietsDiets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order. | Dietary supplement | High Phytosterols Diet, Low Phyto Diet, Medium Phytosterols |
Primary outcome
Fecal cholesterol excretion
Time frame: At the end of week 4 on each diet
1 secondary outcome
intestinal cholesterol absorption
Time frame: At the end of week 4 on each diet
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 19 Apr 2012.
- Results publication: PubMed 19889819Racette SB, Lin X, Lefevre M, Spearie CA, Most MM, Ma L, Ostlund RE Jr. Dose effects of dietary phytosterols on cholesterol metabolism: a controlled feeding study. Am J Clin Nutr. 2010 Jan;91(1):32-8. doi: 10.3945/ajcn.2009.28070. Epub 2009 Nov 4.
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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.
Richard Ostlund, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different amount of phytosterols are added into diets in people with Hypercholesterolemia and Coronary Heart Disease, run by Washington University School of Medicine 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 8 inclusion and 6 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 19 Apr 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 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. Some participants in this study may receive a placebo. 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?
Fecal cholesterol excretion (time frame: At the end of week 4 on each diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00860054, which also lists 1 linked publication.
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 19 Apr 2012.