NCT02270164

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

October 9, 2014

Last Update Submit

May 18, 2016

Conditions

Lipid Metabolism Disorders

Keywords

LipidsCholesterolDietary SupplementsCynara scolymusSafety

Outcome Measures

Primary Outcomes (1)

  • Change in Concentrations of High Density Lipoprotein Cholesterol

    3 months

Study Arms (2)

Artichoke Leaf Extract

EXPERIMENTAL

Pycrinil® 100 mg/flaxseed oil 380 mg liquid filled hard plant based capsules (Licaps®) twice daily with food

Dietary Supplement: Artichoke Leaf Extract

Placebo

PLACEBO COMPARATOR

Placebo/flaxseed oil 380 mg liquid filled hard plant based capsules (Licaps®) twice daily with food

Other: Placebo

Interventions

Artichoke Leaf ExtractDIETARY_SUPPLEMENT

Capsule

Also known as: Pycrinil
Artichoke Leaf Extract
PlaceboOTHER

Capsule

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related 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.

    PMID: 18424099BACKGROUND

  • 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.

    PMID: 10758778BACKGROUND

  • 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.

    PMID: 22746542BACKGROUND

  • 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.

    PMID: 23543518BACKGROUND

MeSH Terms

Conditions

Lipid Metabolism Disorders

Interventions

artichoke leaf

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Daniel M Riche, PharmD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 21, 2014

Study Start

October 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations

US(1)