Clinical trial NCT02270164: The Impact of Artichoke Leaf Extract on Blood Cholesterol: Primary Study
Official title: The Impact of Artichoke Leaf Extract on Blood Cholesterol: Primary Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lipid Metabolism Disorders
Keywords: Lipids
Cholesterol
Dietary Supplements
Cynara scolymus
Safety
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Indena S.p.A
First posted: 2014-10-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* HDL cholesterol \<40 mg/dL in men or \<50 mg/dL in women
* BMI ≥25 kg/m2.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Concentrations of High Density Lipoprotein Cholesterol
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Daniel M Riche, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bundy R, Walker AF, Middleton RW, Wallis C, Simpson HC. Artichoke leaf extract (Cynara scolymus) reduces plasma cholesterol in otherwise healthy hypercholesterolemic adults: a randomized, double blind placebo controlled trial. Phytomedicine. 2008 Sep;15(9):668-75. doi: 10.1016/j.phymed.2008.03.001.
citation: Englisch W, Beckers C, Unkauf M, Ruepp M, Zinserling V. Efficacy of Artichoke dry extract in patients with hyperlipoproteinemia. Arzneimittelforschung. 2000 Mar;50(3):260-5. doi: 10.1055/s-0031-1300196.
citation: Rondanelli M, Giacosa A, Opizzi A, Faliva MA, Sala P, Perna S, Riva A, Morazzoni P, Bombardelli E. Beneficial effects of artichoke leaf extract supplementation on increasing HDL-cholesterol in subjects with primary mild hypercholesterolaemia: a double-blind, randomized, placebo-controlled trial. Int J Food Sci Nutr. 2013 Feb;64(1):7-15. doi: 10.3109/09637486.2012.700920. Epub 2012 Jun 29.
citation: Wider B, Pittler MH, Thompson-Coon J, Ernst E. Artichoke leaf extract for treating hypercholesterolaemia. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003335. doi: 10.1002/14651858.CD003335.pub3.