The Effect of BiosLife on Serum Lipids

May 5, 2008 updated by: University of Utah

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Cardiovascular Genetics, University of Utah, 420 Chipeta Way, Room 1160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LDL cholesterol
Time Frame: 12 weeks
12 weeks
HDL cholesterol
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
triglycerides
Time Frame: 12 weeks
12 weeks
LDL particle number
Time Frame: 12 weeks
12 weeks
LDL particle size distribution
Time Frame: 12 weeks
12 weeks
HDL particle number
Time Frame: 12 weeks
12 weeks
HDL particle size distribution
Time Frame: 12 weeks
12 weeks
VLDL particle number
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Unicity International

Investigators

  • Principal Investigator: Paul N Hopkins, MD, MSPH, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

July 1, 2007

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 5, 2007

First Posted (ESTIMATE)

April 6, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2008

Last Update Submitted That Met QC Criteria

May 5, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BiosLife 2005-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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