Evaluation of the lipid-lowering effects of the BruMeChol™ dietary supplement in subjects with mild hypercholesterolemia

Not Applicable

Completed

• Conditions: mild hypercholesterolemia; cardiovascular diseases; Cardiovascular - Other cardiovascular diseases; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12619000170123
• Lead Sponsor: IRCCS INRCA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-05
• Study Completion: 2020-04-20
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

blood total cholesterol levels between 200 and 250 mg/dL
- no history of clinically relevant cardiovascular events
- signed informed consent form

Exclusion Criteria

- current therapy with statins or food supplements with lipid-reducing effect
- total cholesterol > 250 or < 200 mg/dl;
- therapy with anticoagulants;
- hypothyroidism, orhyperthyroidism
- insulin-dependent diabetes or diabetes associated with macrovascular complications)
- intestinal malabsorption;
- acute illnesses
- neoplastic disease or < 1-year life expectancy;
- statin non-related liver disease
- severe chronic renal failure
- allergy/intolerance to one or more components of dietary supplement or placebo
- participation in another clinical trial of intervention in the previous three months.
- presence of cognitive disorders and other impediments that do not guarantee the correct adherence to the study treatments;
- current or presumed pregnancy and pregnancy planning;
- incapacity, impossibility or unavailability to sign the written consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified