HypercholesterolemiaPRV-08009NCT00945737
A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia
A study testing Soy protein; 25 grams/day in people with Hypercholesterolemia, run by Solae, LLC at 2 sites in United States.
Trial summary
The objectives of the trial are to determine whether a non-commercial soy protein product, consumed as part of a low-saturated fat diet, reduces low-density lipoprotein cholesterol (LDL-C) concentrations in men and women with mild to moderate hypercholesterolemia, and affects other aspects related biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Soy protein; 25 grams/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Aug 2009
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- 18-79 years of age
- Fasting LDL-Cholesterol level borderline to high range taking no cholesterol lowering medications
- otherwise judged to be in good health, willing to maintain a stable body weight and follow the TLC diet throughout the trial.
Who cannot join
- CHD or CHD risk equivalent
- Pregnancy
- Food allergy or sensitivity to soy or milk protein
- Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications
- Poorly controlled hypertension
- Cancer treated within prior 2 years
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Provident Clinical Research
Addison, Illinois, 60101
Provident Clinical Research
Bloomington, Indiana, 47403
About this study
Official title: A Randomized, Controlled Parallel Study to Evaluate the Effects of a Non-Commercial Soy Protein Product on Fecal Bile Acids and Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia
The objectives of the trial are to determine whether a non-commercial soy protein product, consumed as part of a low-saturated fat diet, reduces low-density lipoprotein cholesterol (LDL-C) concentrations in men and women with mild to moderate hypercholesterolemia, and affects other aspects related biomarkers.
- Conditions
- Hypercholesterolemia
- Being tested
- Soy protein; 25 grams/day, Control protein
- Keywords
- hypercholesterolemia, cholesterol, soy
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy protein; 25 grams/dayDietary supplement
Soy protein
Control proteinDietary supplement
Milk protein
| Study group | Role | What they receive |
|---|---|---|
| Soy protein | Active comparator | Not described Receives: Dietary Supplement: Soy protein; 25 grams/day |
| Milk protein | Placebo comparator | Not described Receives: Dietary Supplement: Control protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C
Measured: 4 weeks
Secondary outcomes (1)
Changes in other lipid levels and other related biomarkers
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionAug 2009
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solae, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Reeves, DO, Principal investigator, Provident Clinical ResearchMano Patri, MD, Principal investigator, Provident Clinical Research, Addison, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945737
- Sponsor's protocol ID
- PRV-08009
- Acronym
- PRV-08009
- Status last verified
- Jun 2012
- First submitted
- 21 Jul 2009
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Maki KC, Butteiger DN, Rains TM, Lawless A, Reeves MS, Schasteen C, Krul ES. Effects of soy protein on lipoprotein lipids and fecal bile acid excretion in men and women with moderate hypercholesterolemia. J Clin Lipidol. 2010 Nov-Dec;4(6):531-42. doi: 10.1016/j.jacl.2010.09.001. Epub 2010 Oct 1.
PubMed 21122701
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Parallel Study to Evaluate the Effects of a Non-Commercial Soy Protein Product on Fecal Bile Acids and Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00945737
- Acronym / sponsor ID
- PRV-08009 / PRV-08009
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, cholesterol, soy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Solae, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 24 Jul 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.
The objectives of the trial are to determine whether a non-commercial soy protein product, consumed as part of a low-saturated fat diet, reduces low-density lipoprotein cholesterol (LDL-C) concentrations in men and women with mild to moderate hypercholesterolemia, and affects other aspects related biomarkers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy protein | Active comparator | Dietary Supplement: Soy protein; 25 grams/day |
| Milk protein | Placebo comparator | Dietary Supplement: Control protein |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female
- 18-79 years of age
- Fasting LDL-Cholesterol level borderline to high range taking no cholesterol lowering medications
- otherwise judged to be in good health, willing to maintain a stable body weight and follow the TLC diet throughout the trial.
Key exclusion criteria (6 listed)
- CHD or CHD risk equivalent
- Pregnancy
- Food allergy or sensitivity to soy or milk protein
- Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications
- Poorly controlled 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 |
|---|---|---|
| Soy protein; 25 grams/daySoy protein | Dietary supplement | Soy protein |
| Control proteinMilk protein | Dietary supplement | Milk protein |
Primary outcome
The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C
Time frame: 4 weeks
1 secondary outcome
Changes in other lipid levels and other related biomarkers
Time frame: 4 weeks
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 Jun 2012.
- Derived from this study: PubMed 21122701Maki KC, Butteiger DN, Rains TM, Lawless A, Reeves MS, Schasteen C, Krul ES. Effects of soy protein on lipoprotein lipids and fecal bile acid excretion in men and women with moderate hypercholesterolemia. J Clin Lipidol. 2010 Nov-Dec;4(6):531-42. doi: 10.1016/j.jacl.2010.09.001. Epub 2010 Oct 1.
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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.
Matthew Reeves, DO principal investigator
Provident Clinical Research
Mano Patri, MD principal investigator
Provident Clinical Research, Addison, IL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy protein; 25 grams/day in people with Hypercholesterolemia, run by Solae, LLC at 2 sites 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 4 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 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C (time frame: 4 weeks). 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 NCT00945737, 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 7 Jun 2012.