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OpenTrials
Completed

NCT Number: NCT00457756

The Effect of BiosLife on Serum Lipids

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Salt Lake City, Utah, 84108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BiosLife Complete

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. LDL cholesterol

    Time frame: 12 weeks

  2. HDL cholesterol

    Time frame: 12 weeks

Secondary outcomes

  1. triglycerides

    Time frame: 12 weeks

  2. LDL particle number

    Time frame: 12 weeks

  3. LDL particle size distribution

    Time frame: 12 weeks

  4. HDL particle number

    Time frame: 12 weeks

  5. HDL particle size distribution

    Time frame: 12 weeks

  6. VLDL particle number

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Unicity International

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 6, 2007
Registry last updated
May 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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