The Effect of BiosLife on Serum Lipids

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of an Integrative Dietary Supplement on the Lipid Profile of Subjects With Hypercholesterolemia

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: BiosLife Complete
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>Cohort I subjects will take supplement for 12 weeks | Dietary Supplement: BiosLife Complete<br> <br> |
| Placebo Comparator: II<br>Cohort II will take placebo for 12 weeks | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol |  | 12 weeks | 
| HDL cholesterol |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| triglycerides |  | 12 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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policosanol, LDL cholesterol, HDL cholesterol, natural supplement, guar gum, phytosterols, chrysanthemum