The Effect of BiosLife on Serum Lipids

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: BiosLife Complete; Dietary Supplement: Placebo

• Registration Number: NCT00457756
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-04-04
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-06
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-05
• Last Update Posted: 2008-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	BiosLife Complete	Cohort I subjects will take supplement for 12 weeks
II	Placebo	Cohort II will take placebo for 12 weeks

Primary Outcome Measures

Name	Time	Method
LDL cholesterol	12 weeks
HDL cholesterol	12 weeks

Secondary Outcome Measures

Name	Time	Method
VLDL particle number	12 weeks
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

Trial Locations

Locations (1)

Cardiovascular Genetics, University of Utah, 420 Chipeta Way, Room 1160; 🇺🇸 Salt Lake City, Utah, United States