Status:

COMPLETED

The Effect of BiosLife on Serum Lipids

Lead Sponsor:

University of Utah

Collaborating Sponsors:

Unicity International

Conditions:

Hypercholesterolemia

Eligibility:

All Genders

18-85 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2007

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00457756

Start Date

January 1 2007

End Date

July 1 2007

Last Update

May 8 2008

Active Locations (1)

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1

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

Salt Lake City, Utah, United States, 84108

The Effect of BiosLife on Serum Lipids | DecenTrialz