Status:
WITHDRAWN
The Impact of Artichoke Leaf Extract on Blood Cholesterol: Primary Study
Lead Sponsor:
University of Mississippi Medical Center
Collaborating Sponsors:
Indena S.p.A
Conditions:
Lipid Metabolism Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pycrinil® is a purified extract of the artichoke leaf. Artichoke leaf extract (ALE) has some clinical trial data suggesting benefit in the treatment of cholesterol disorders in several countries, but ...
Detailed Description
Subjects will be divided into one of two groups: (1) Pycrinil®/flaxseed oil or (2) Placebo/flaxseed oil twice daily with food. The two formulations will be identical in appearance and standardized by ...
Eligibility Criteria
Inclusion
- ≥18 years of age
- HDL cholesterol \<40 mg/dL in men or \<50 mg/dL in women
- BMI ≥25 kg/m2.
Exclusion
- Patient on statins
- Triglycerides \>400 mg/dL
- Low density lipoprotein (LDL) \>190 mg/dL
- Significant hepatic disease (i.e., documented diagnosis of hepatic cancer, hepatitis, or cirrhosis)
- Significant renal disease (i.e., most recent glomerular filtration rate \<30 mL/min/1.73 m2)
- Significant gastrointestinal tract disease (documented diagnosis of malabsorption disorder, GI cancer, or uncontrolled inflammatory bowel disease)
- History of transplant
- Women of reproductive potential not receiving birth control
- Pregnant/nursing women
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02270164
Start Date
October 1 2014
End Date
February 1 2016
Last Update
May 19 2016
Active Locations (1)
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1
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216