Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2007-01-31
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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I
Cohort I subjects will take supplement for 12 weeks
BiosLife Complete
II
Cohort II will take placebo for 12 weeks
Placebo
Interventions
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BiosLife Complete
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
Yes
Sponsors
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Unicity International
UNKNOWN
University of Utah
OTHER
Responsible Party
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University of Utah
Principal Investigators
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Paul N Hopkins, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Cardiovascular Genetics, University of Utah, 420 Chipeta Way, Room 1160
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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BiosLife 2005-4
Identifier Type: -
Identifier Source: org_study_id