Lipid Metabolism DisordersNCT02270164
The Impact of Artichoke Leaf Extract on Blood Cholesterol: Primary Study
A study testing Artichoke Leaf Extract in people with Lipid Metabolism Disorders, run by University of Mississippi Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism Disorders
- What is being tested?
- Artichoke Leaf Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- HDL cholesterol <40 mg/dL in men or <50 mg/dL in women
- BMI ≥25 kg/m2.
Who cannot join
- 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)
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- History of transplant
- Women of reproductive potential not receiving birth control
- Pregnant/nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
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.
Read the 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.
- Conditions
- Lipid Metabolism Disorders
- Being tested
- Artichoke Leaf Extract, Placebo
- Keywords
- Lipids, Cholesterol, Dietary Supplements, Cynara scolymus, Safety
- Medical subject headings
- Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artichoke Leaf ExtractDietary supplement
Also called Pycrinil
Capsule
PlaceboOther
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Artichoke Leaf Extract | Experimental | Pycrinil® 100 mg/flaxseed oil 380 mg liquid filled hard plant based capsules (Licaps®) twice daily with food Receives: Dietary Supplement: Artichoke Leaf Extract |
| Placebo | Placebo comparator | Placebo/flaxseed oil 380 mg liquid filled hard plant based capsules (Licaps®) twice daily with food Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Concentrations of High Density Lipoprotein Cholesterol
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Sponsor discontinued funding due to higher than anticipated manufacturer costs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lipid Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Indena S.p.A
- Responsible party
- Principal investigator, Daniel Riche, University of Mississippi Medical Center
- Investigators
- Daniel M Riche, PharmD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270164
- Sponsor's protocol ID
- 2014-0167
- Status last verified
- May 2016
- First submitted
- 9 Oct 2014
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18424099Englisch 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.
PubMed 10758778Rondanelli 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.
PubMed 22746542Wider 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.
PubMed 23543518
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Artichoke Leaf Extract on Blood Cholesterol: Primary Study
- ClinicalTrials.gov ID
- NCT02270164
- Acronym / sponsor ID
- 2014-0167
- Conditions
- Lipid Metabolism Disorders
- Keywords
- Lipids, Cholesterol, Dietary Supplements, Cynara scolymus, Safety
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor discontinued funding due to higher than anticipated manufacturer costs
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Indena S.p.A
- Study start
- Oct 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artichoke Leaf Extract | Experimental | Dietary Supplement: Artichoke Leaf ExtractPycrinil® 100 mg/flaxseed oil 380 mg liquid filled hard plant based capsules (Licaps®) twice daily with food |
| Placebo | Placebo comparator | Other: PlaceboPlacebo/flaxseed oil 380 mg liquid filled hard plant based capsules (Licaps®) twice daily with food |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years of age
- HDL cholesterol <40 mg/dL in men or <50 mg/dL in women
- BMI ≥25 kg/m2.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artichoke Leaf ExtractAlso: PycrinilCapsule | Dietary supplement | Artichoke Leaf Extract |
| PlaceboCapsule | Other | Placebo |
Primary outcome
Change in Concentrations of High Density Lipoprotein Cholesterol
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Background: PubMed 18424099Bundy 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.
- Background: PubMed 10758778Englisch 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.
- Background: PubMed 22746542Rondanelli 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.
- Background: PubMed 23543518Wider 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel M Riche, PharmD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artichoke Leaf Extract in people with Lipid Metabolism Disorders, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Concentrations of High Density Lipoprotein Cholesterol (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02270164, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.