50 Caucasian never-treated hypertensive outpatients, 27 males and 23 women, age range 42-60 years (mean+SD=52+7), showing normal glucose tolerance but 1-h post load plasma glucose >155 mg/dl, during the OGTT.

Hypertension

After enrollment, all patients were encouraged to make lifestyle changes according with current guidelines, moreover it was also recommended to take silybin coniugated to vitamin E and phosphatidylcholine that shows higher intestinal absorption and bioavailability (Indena, IBI-Lorenzini spa Italy: Realsil®), as granules for oral solution at a dose of 3 g bid. Each subject was re-evaluated monthly performing a clinical examination to consider the opportunity of antihypertensive treatment. Finally, inflammatory, metabolic and hemodynamic parameters were assessed after 6 months of treatment. In particular, at the end of the follow-up period, a new OGTT was performed, to test the effects of silybin on glucose tolerance and IR status.

Silybin

Effects of Silybin in Hypertensive Patients

Metabolic and Vascular Effects of Silybin in Hypertensive Patients With High One-hour Post-load Plasma Glucose: a Single Arm Pilot Study

Fasting plasma glucose (mg/dL) will be measured after six months of treatment with silybin

2h post-load plasma glucose (mg/dL) will be determined after six months of treatment with silybin

Fasting insulin (mU/L) will be measured after six months of treatment with silybin

Total cholesterol (mg/dL) will be measured after six months of treatment with silybin

HDL-cholesterol (mg/dL) will be measured after six months of treatment with silybin

LDL-cholesterol (mg/dL) will be measured after six months of treatment with silybin

SBP (mmHg) will be measured after six months of treatment with silybin .

DBP (mmHg) will be measured after six months of treatment with silybin

PP will be measured after six months of treatment with silybin.

PWV (m/s) will be measured after six months of treatment with silybin

AI will be measured after six months of treatment with silybin

AP (mmHg) will be measured after six months of treatment with silybin

Measurement of serum hs-CRPhs-CRP (mg/dL) will be measured after six moths of treatment with silybin

Maria Perticone

Principal Investigator

University Magna Graecia

Pilot, single arm, interventional, longitudinal study

Lifestyle counseling plus three month administration of nutraceutical mixture (2 soft gelatin capsules of 800 mg per day)

Lifestyle counseling plus three month administration of placebo formulation (2 soft gelatin capsules of 800 mg per day)

Non-alcoholic Fatty Liver Disease

Lifestyle counseling, administration of a nutraceutical mixture: fish oil 70% DHA (docosahexaenoic acid), phosphatidylcholine concentrated in sunflower oil, silymarin, choline bitartrate, curcumin, D-α-tocopherol; choline (82,5 mg, corresponding to 15% of the average intake of 550 mg per day in an adult man)

nutraceutical mixture

Lifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture

placebo

IRCCS Neuromed

Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

Clinical Trial on the Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

hematic levels of direct and indirect bilirubin

C Reactive Protein (CRP), interleukin (IL)-6, IL-1β, IL-8, IL-10, Receptor for Advanced Glycation End Products (RAGE), Advanced Glycation End Products (AGE), insulin-like growth factor-1 (IGF-1)

Factor VII, fibrinogen, thrombin generation with and without thrombomodulin, antithrombin (AT), tissue-type Plasminogen Activator (t-PA), Plasminogen Activator Inhibitor-1(PAI-1), thrombin activatable fibrinolysis inhibitor (TAFI) and activated TAFI (TAFIa), plasmin-antiplasmin complex, plasma fibrinolytic capacity

glycemia, triglycerides, HDL cholesterol, insulin e insulin-resistance (HOMA-IR homeostasis model assessment-estimated insulin resistance), adiponectin

total cytokeratin-18 (M65 antigene), M30 and M65/M65ED, soluble fas and soluble fas ligand

silybin/köklük

Effects of Silybin in Hypertensive Patients

Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

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