The Effect of BiosLife on Serum Lipids

NCT00457756 | Completed

• 1 other identifier: BiosLife 2005-4
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

LDL cholesterol; HDL cholesterol; natural supplement; guar gum; phytosterols; policosanol; chrysanthemum

Outcome Measures

Primary Outcomes (2)

• LDL cholesterol

  12 weeks

• HDL cholesterol

  12 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

I

ACTIVE COMPARATOR

Cohort I subjects will take supplement for 12 weeks

Dietary Supplement: BiosLife Complete

II

PLACEBO COMPARATOR

Cohort II will take placebo for 12 weeks

Dietary Supplement: Placebo

Interventions

BiosLife Complete DIETARY_SUPPLEMENT

I

Placebo DIETARY_SUPPLEMENT

II

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Unicity International: collaborator

Study Sites (1)

Cardiovascular Genetics, University of Utah, 420 Chipeta Way, Room 1160

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Paul N Hopkins, MD, MSPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 6, 2007
• Study Start: January 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: May 8, 2008

Record last verified: 2008-05

Locations

US (1)