Status:
COMPLETED
LDL-cholesterol Lowering Effect of a New Dietary Supplement
Lead Sponsor:
Ispharm srl
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this study was to assess the lipid-lowering activity and safety of a dietary supplement containing monacolin K, L-arginine, coenzyme Q10 and ascorbic acid (vitamin C). Twenty both gender c...
Detailed Description
Between July 2016 and April 2017 eligible patients were recruited among the outpatients attending the Obesity Center of the Endocrinology Unit 1, Cisanello Hospital, Pisa, Italy. Patients aged 18-75 y...
Eligibility Criteria
Inclusion
- serum LDL-C between130-180 mg/dL, not significantly modified by an appropriate dietetic regimen
Exclusion
- pregnancy or breast-feeding
- known liver, renal or muscle diseases
- serum triglycerides (TG) greater than 350 mg/dL
- previous cardiovascular events
- concomitant neoplastic or immunodepressive disease
- use of lipid-lowering drugs or dietary supplements within the last 3 weeks
- concurrent use of thiazide diuretics, oral contraceptives containing estrogen or progestogen, systemic corticosteroids
- use of psycho-active substances, drug or alcohol abuse
- neurological or psychiatric diseases that could affect consent validity or impair the patient's adherence to the study protocol
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03425630
Start Date
July 1 2016
End Date
April 1 2017
Last Update
February 12 2018
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