Status:
COMPLETED
Nutraceuticals and Vascular Remodelling
Lead Sponsor:
Marcello Rattazzi
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
30-65 years
Brief Summary
Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular prevention in a se...
Eligibility Criteria
Inclusion
- Total Cholesterol \> 150 mg/dl and \< 250 mg/dl;
- Triglycerides \> 150 mg/dl and \< 500 mg/dl;
- Fasting glucose \< 126 mg/dl;
- Stable antihypertensive treatment (at least for 6 months) in presence of hypertension.
Exclusion
- Total Cholesterol \> 250 mg/dl
- Triglycerides \> 500 mg/dl
- Previous statin therapy (last 6 months);
- Treatment with hypoglycemic agents and/or fasting glucose \> 126 mg/dl;
- Chronic gastrointestinal disorders;
- Chronic kidney disease (eGFR \< 60 ml/min/1.73 m2);
- Concomitant treatment with drugs potentially interfering with glucose and lipid metabolism; - History of cardiovascular diseases;
- Proven intolerance to any component of the nutraceutical product;
- Pregnancy or breastfeeding.
Key Trial Info
Start Date :
May 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04433429
Start Date
May 1 2016
End Date
December 1 2017
Last Update
June 16 2020
Active Locations (1)
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1
Azienda Ospedaliera di Padova
Padua, Italy, 35125