Lipid Metabolism Disorders
Conditions
Keywords
Lipids, Cholesterol, Dietary Supplements, Cynara scolymus, Safety
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.
Interventions
DIETARY_SUPPLEMENTArtichoke Leaf Extract
Capsule
OTHERPlacebo
Capsule
Sponsors
Indena S.p.A
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Concentrations of High Density Lipoprotein Cholesterol | 3 months |
Countries
United States
Outcome results
None listed