The Effect of BiosLife on Serum Lipids
Completed · Not applicable · Has a placebo group
Conditions studied: Hypercholesterolemia
In brief
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.
Key facts
- Study ID
- NCT00457756
- Run by
- University of Utah
- People needed
- 100
- Starts
- 2007-01-01
- Expected to finish
- 2007-07-01
- Last updated by the study team
- 2008-05-08
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cardiovascular Genetics, University of Utah, 420 Chipeta Way, Room 1160 — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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