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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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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

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Lipid Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Artichoke Leaf Extract

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

Group Type EXPERIMENTAL

Artichoke Leaf Extract

Intervention Type DIETARY_SUPPLEMENT

Capsule

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Capsule

Interventions

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Artichoke Leaf Extract

Capsule

Intervention Type DIETARY_SUPPLEMENT

Placebo

Capsule

Intervention Type OTHER

Other Intervention Names

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Pycrinil

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes