The Effect of BiosLife on Serum Lipids

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: BiosLife Complete; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00457756

BiosLife 2005-4

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups, including a placebo group

I

Active Comparator group

Description:

Cohort I subjects will take supplement for 12 weeks

Treatment:

Dietary Supplement: BiosLife Complete

II

Placebo Comparator group

Description:

Cohort II will take placebo for 12 weeks

Treatment:

Dietary Supplement: Placebo