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The Effect of BiosLife on Serum Lipids

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BiosLife Complete
Placebo
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring LDL cholesterol, HDL cholesterol, natural supplement, guar gum, phytosterols, policosanol, chrysanthemum

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

I

II

Arm Description

Cohort I subjects will take supplement for 12 weeks

Cohort II will take placebo for 12 weeks

Outcomes

Primary Outcome Measures

LDL cholesterol
HDL cholesterol

Secondary Outcome Measures

triglycerides
LDL particle number
LDL particle size distribution
HDL particle number
HDL particle size distribution
VLDL particle number

Full Information

First Posted
April 4, 2007
Last Updated
May 5, 2008
Sponsor
University of Utah
Collaborators
Unicity International
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1. Study Identification

Unique Protocol Identification Number
NCT00457756
Brief Title
The Effect of BiosLife on Serum Lipids
Official Title
The Effect of an Integrative Dietary Supplement on the Lipid Profile of Subjects With Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Utah
Collaborators
Unicity International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
LDL cholesterol, HDL cholesterol, natural supplement, guar gum, phytosterols, policosanol, chrysanthemum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Description
Cohort I subjects will take supplement for 12 weeks
Arm Title
II
Arm Type
Placebo Comparator
Arm Description
Cohort II will take placebo for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
BiosLife Complete
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
LDL cholesterol
Time Frame
12 weeks
Title
HDL cholesterol
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
triglycerides
Time Frame
12 weeks
Title
LDL particle number
Time Frame
12 weeks
Title
LDL particle size distribution
Time Frame
12 weeks
Title
HDL particle number
Time Frame
12 weeks
Title
HDL particle size distribution
Time Frame
12 weeks
Title
VLDL particle number
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul N Hopkins, MD, MSPH
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Genetics, University of Utah, 420 Chipeta Way, Room 1160
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

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The Effect of BiosLife on Serum Lipids

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