Clinical trial NCT00457756: The Effect of BiosLife on Serum Lipids
Official title: The Effect of an Integrative Dietary Supplement on the Lipid Profile of Subjects With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: LDL cholesterol
HDL cholesterol
natural supplement
guar gum
phytosterols
policosanol
chrysanthemum
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Unicity International
First posted: 2007-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: LDL cholesterol
timeFrame: 12 weeks
measure: HDL cholesterol
timeFrame: 12 weeks
Secondary outcomes:
measure: triglycerides
timeFrame: 12 weeks
measure: LDL particle number
timeFrame: 12 weeks
measure: LDL particle size distribution
timeFrame: 12 weeks
measure: HDL particle number
timeFrame: 12 weeks
measure: HDL particle size distribution
timeFrame: 12 weeks
measure: VLDL particle number
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Cardiovascular Genetics, University of Utah, 420 Chipeta Way, Room 1160
state: Utah
Study officials:
affiliation: University of Utah
name: Paul N Hopkins, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: