An interventional study of Artichoke Leaf Extract and Placebo in Lipid Metabolism Disorders, sponsored by University of Mississippi Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-19.
Sponsored by University of Mississippi Medical Center · Not applicable, Interventional, and Supportive care
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 this effect has not been studied in a U.S. population. The investigators will give ALE or a placebo to overweight men and women with low "good" cholesterol to see if ALE increases their good cholesterol. The investigators will also make sure that ALE is safe.
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 Indena, S.p.A. Patients will be enrolled for a total of 3 months (± 1 week to allow for scheduling flexibility) with a 1 month (± 1 week to allow for scheduling flexibility) first follow-up visit in between enrollment and final visits. At all visits, patients will be asked to monitor for any symptomatic ADE. The first follow-up visit will focus on medication compliance (via pill count) and safety assessment (including laboratories). The final study visit will consist of brief clinical assessment (including anthropometrics), completed lifestyle and physical activity assessments, subjective ADE reporting, and donated blood and urine for clinical laboratory tests. Medication changes are not prohibited during the study period, but must be recorded. Medication bottles will be collected at the first follow-up and final visits; pill counts will be performed to assess compliance.
997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.
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Exclusion Criteria:
Pycrinil® 100 mg/flaxseed oil 380 mg liquid filled hard plant based capsules (Licaps®) twice daily with food
Dietary Supplement: Artichoke Leaf Extract
Placebo/flaxseed oil 380 mg liquid filled hard plant based capsules (Licaps®) twice daily with food
Other: Placebo
Capsule
Also known as: Pycrinil
Capsule
Change in Concentrations of High Density Lipoprotein Cholesterol
Time frame: 3 months
This study is withdrawn, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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University of Mississippi Medical Center