The Impact of Artichoke Leaf Extract on Blood Cholesterol: Primary Study

Lipid Metabolism Disorders Clinical Trial

Official title:

The Impact of Artichoke Leaf Extract on Blood Cholesterol: Primary Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02270164
• Other study ID #: 2014-0167
• Status: Withdrawn
• Phase: N/A
• First received: October 9, 2014
• Last updated: May 18, 2016
• Start date: October 2014
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

Dietary Supplement:
• Artichoke Leaf Extract
Capsule

Other:
• Placebo
Capsule

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	Indena S.p.A

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Concentrations of High Density Lipoprotein Cholesterol		3 months	No