Hypercholesterolemia
Conditions
Keywords
LDL cholesterol, HDL cholesterol, natural supplement, guar gum, phytosterols, policosanol, chrysanthemum
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.
Interventions
DIETARY_SUPPLEMENTBiosLife Complete
DIETARY_SUPPLEMENTPlacebo
Sponsors
Unicity International
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HDL cholesterol | 12 weeks |
| LDL cholesterol | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| LDL particle number | 12 weeks |
| LDL particle size distribution | 12 weeks |
| HDL particle number | 12 weeks |
| HDL particle size distribution | 12 weeks |
| VLDL particle number | 12 weeks |
| triglycerides | 12 weeks |
Countries
United States
Outcome results
None listed