HypercholesterolemiaNCT00457756
The Effect of BiosLife on Serum Lipids
A study testing BiosLife Complete in people with Hypercholesterolemia, run by University of Utah at 1 site in United States.
Trial summary
This is a double-blind, placebo-controlled study to assess the effectiveness of BiosLife in lowering serum LDL cholesterol and raising HDL cholesterol. BiosLife is a natural supplement (mixed in water and taken twice daily) which contains guar gum and other natural soluble fibers, phytosterols, policosanol, and a… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- BiosLife Complete
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jul 2007
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- LDL-C 110 - 190 mg/dL
- For current lipid-lowering prescription therapy users, the dose of lipid-lowering medication must have been constant for 3 months with no current plan for change in dose.
- Age 18 - 85 years
Who cannot join
- Type 1 diabetes
- Severe hypertension, defined as at least 180 / 100 mmHg
- Any other health condition that may interfere with the study results, as judged by the principle investigator
- Allergy against any of the ingredients in the tested product
- Any medical condition, in which fiber consumption is contraindicated (e.g. Crohn's disease
- The use of nutritional supplements during the last two months containing one or more similar ingredients, as the tested supplement.
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- History of alcohol or drug abuse, psychological or other mental issues that are likely to invalidate informed consent, or limit the ability of the patient to comply with the protocol requirements
- Participation in any other studies involving investigational or marketed product concomitantly or within one month prior to entry into the study
- Pregnant or breast feeding
- Persons who eat only 1 meal per day
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Genetics, University of Utah, 420 Chipeta Way, Room 1160
Salt Lake City, Utah, 84108
About this study
Official title: The Effect of an Integrative Dietary Supplement on the Lipid Profile of Subjects With Hypercholesterolemia
This is a double-blind, placebo-controlled study to assess the effectiveness of BiosLife in lowering serum LDL cholesterol and raising HDL cholesterol. BiosLife is a natural supplement (mixed in water and taken twice daily) which contains guar gum and other natural soluble fibers, phytosterols, policosanol, and a proprietary chrysanthemum extract. Approximately 100 subjects with baseline LDL cholesterol of 110-190 mg/dL will be randomized in a 2:1 ratio to BiosLife or a look-alike placebo. Changes in lipids from baseline will be assessed at 6 weeks and 12 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- BiosLife Complete, Placebo
- Keywords
- LDL cholesterol, HDL cholesterol, natural supplement, guar gum, phytosterols, policosanol, chrysanthemum
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiosLife CompleteDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Cohort I subjects will take supplement for 12 weeks Receives: Dietary Supplement: BiosLife Complete |
| II | Placebo comparator | Cohort II will take placebo for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol
Measured: 12 weeks
HDL cholesterol
Measured: 12 weeks
Secondary outcomes (6)
triglycerides
Measured: 12 weeks
LDL particle number
Measured: 12 weeks
LDL particle size distribution
Measured: 12 weeks
HDL particle number
Measured: 12 weeks
HDL particle size distribution
Measured: 12 weeks
VLDL particle number
Measured: 12 weeks
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 2007
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Unicity International
- Investigators
- Paul N Hopkins, MD, MSPH, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457756
- Sponsor's protocol ID
- BiosLife 2005-4
- Status last verified
- May 2008
- First submitted
- 4 Apr 2007
- Last updated
- 8 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Integrative Dietary Supplement on the Lipid Profile of Subjects With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00457756
- Acronym / sponsor ID
- BiosLife 2005-4
- Conditions
- Hypercholesterolemia
- Keywords
- LDL cholesterol, HDL cholesterol, natural supplement, guar gum, phytosterols, policosanol, chrysanthemum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Unicity International
- Study start
- Jan 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (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.
This is a double-blind, placebo-controlled study to assess the effectiveness of BiosLife in lowering serum LDL cholesterol and raising HDL cholesterol. BiosLife is a natural supplement (mixed in water and taken twice daily) which contains guar gum and other natural soluble fibers, phytosterols, policosanol, and a proprietary chrysanthemum extract. Approximately 100 subjects with baseline LDL cholesterol of 110-190 mg/dL will be randomized in a 2:1 ratio to BiosLife or a look-alike placebo. Changes in lipids from baseline will be assessed at 6 weeks and 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Dietary Supplement: BiosLife CompleteCohort I subjects will take supplement for 12 weeks |
| II | Placebo comparator | Dietary Supplement: PlaceboCohort II will take placebo for 12 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- LDL-C 110 - 190 mg/dL
- For current lipid-lowering prescription therapy users, the dose of lipid-lowering medication must have been constant for 3 months with no current plan for change in dose.
- Age 18 - 85 years
Key exclusion criteria (10 listed)
- Type 1 diabetes
- Severe hypertension, defined as at least 180 / 100 mmHg
- Any other health condition that may interfere with the study results, as judged by the principle investigator
- Allergy against any of the ingredients in the tested product
- Any medical condition, in which fiber consumption is contraindicated (e.g. Crohn's 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 |
|---|---|---|
| BiosLife Complete | Dietary supplement | I |
| Placebo | Dietary supplement | II |
Primary outcome
LDL cholesterol
Time frame: 12 weeks
HDL cholesterol
Time frame: 12 weeks
6 secondary outcomes
triglycerides
Time frame: 12 weeks
LDL particle number
Time frame: 12 weeks
LDL particle size distribution
Time frame: 12 weeks
HDL particle number
Time frame: 12 weeks
HDL particle size distribution
Time frame: 12 weeks
VLDL particle number
Time frame: 12 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 8 May 2008.
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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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.
Paul N Hopkins, MD, MSPH principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiosLife Complete in people with Hypercholesterolemia, run by University of Utah 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 3 inclusion and 10 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 8 May 2008. 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?
LDL cholesterol (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 8 May 2008.