The Effect of BiosLife on Serum Lipids

This study has been completed.
Sponsor:
Collaborator:
Unicity International
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00457756
First received: April 4, 2007
Last updated: May 5, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
Hypercholesterolemia
Dietary Supplement: BiosLife Complete
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of an Integrative Dietary Supplement on the Lipid Profile of Subjects With Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • LDL cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HDL cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • LDL particle number [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • LDL particle size distribution [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HDL particle number [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HDL particle size distribution [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • VLDL particle number [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
Cohort I subjects will take supplement for 12 weeks
Dietary Supplement: BiosLife Complete
Placebo Comparator: II
Cohort II will take placebo for 12 weeks
Dietary Supplement: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457756

Locations
United States, Utah
Cardiovascular Genetics, University of Utah, 420 Chipeta Way, Room 1160
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Unicity International
Investigators
Principal Investigator: Paul N Hopkins, MD, MSPH University of Utah
  More Information

No publications provided

Responsible Party: Paul Hopkins, MD, MSPH, University of Utah
ClinicalTrials.gov Identifier: NCT00457756     History of Changes
Other Study ID Numbers: BiosLife 2005-4
Study First Received: April 4, 2007
Last Updated: May 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
LDL cholesterol
HDL cholesterol
natural supplement
guar gum
phytosterols
policosanol
chrysanthemum

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014