The Effect of BiosLife on Serum Lipids

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457756
• Other study ID #: BiosLife 2005-4
• Status: Completed
• Phase: N/A
• First received: April 4, 2007
• Last updated: May 5, 2008
• Start date: January 2007
• Est. completion date: July 2007

Study information

• Verified date: May 2008
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• BiosLife Complete

• Placebo

Locations

Country	Name	City	State
United States	Cardiovascular Genetics, University of Utah, 420 Chipeta Way, Room 1160	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Unicity International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol		12 weeks	No
Primary	HDL cholesterol		12 weeks	No
Secondary	triglycerides		12 weeks	No
Secondary	LDL particle number		12 weeks	No
Secondary	LDL particle size distribution		12 weeks	No
Secondary	HDL particle number		12 weeks	No
Secondary	HDL particle size distribution		12 weeks	No
Secondary	VLDL particle number		12 weeks	No