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European Union Garlic Inflammation Study (EUGIS) in Humans

European Union Garlic Inflammation Study (EUGIS) in Humans. Martijn van Doorn Sonia Espirito Santo. TNO-PH Leiden The Netherlands. CHDR Leiden The Netherlands. Background. No clear indications that ‘garlic’ influences lipid metabolism

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European Union Garlic Inflammation Study (EUGIS) in Humans

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  1. European Union Garlic Inflammation Study (EUGIS) in Humans Martijn van Doorn Sonia Espirito Santo TNO-PH Leiden The Netherlands CHDR Leiden The Netherlands

  2. Background • No clear indications that ‘garlic’ influences lipid metabolism • Indications from cell and animal studies that ‘garlic’ may influence inflammation parameters • Cardiovascular disease (atherosclerosis) shares common features with inflammation • Current treatment strategies for atherosclerosis also focus on inflammation, i.e. lipid lowering drugs like statins)

  3. Aim Study the effects of garlic on inflammatory biomarkers of atherosclerotic disease and on cancer biomarkers in man • Primary endpoint: changes in C-reactive protein ( CRP) • Secondary endpoints: • Indicators of lipid metabolism • Biochemical markers of inflammation • Bloodpressure / heart rate variability • Biomarkers for anti-carcinogenic effects

  4. Inclusion criteria • Able and willing to give informed consent • 90 subjects of either gender • Power calculation to find a reduction of 30% in plasma CRP levels with = 0.05 and a power of 80% about 30 subjects per group are needed. • Aged between 40-75 years • Smoking≥ 10 cigarettes/day and BMI≥ 24.5 kg/m2

  5. Exclusion criteria • Any major clinical significant abnormality detected by a general health questionnaire or by blood sampling • Chronic drug treatment /use of medication, i.e. aspirin or hormone replacement therapy, interfering with the study • Participation in prior studie(s) in the last 3 months • Blood donation, including this study, not according to the guidelines of the blood donation services • Inadequate use of contraceptives • Pregnant or lactating women • History of alcohol or drug abuse • Positive test results for Hepatitis B, Hepatitis C or HIV • Dislike of garlic

  6. Experimental design • Double dummy placebo-controlled trial • 3 parallel groups (n=30) I.C. / screening Intervention period 4 - 5 11-12 weeks -2 0 Blood and urine collection

  7. Groups design • EU-sponsored Printanor 2001: 2.1g/day for 12 weeks = 7 capsules of 300 mg (3 cap at breakfast and 4 cap at dinner) = one medium-large size fresh garlic clove • compliant with European Pharmacopoeia with respect to microbial impurities; • Atorvastatin:40 mg/day for 12 weeks = 1 tablet of 40 mg at dinner) • Placebo: tablets every day for 12 weeks

  8. Measurements • Clinical: Blood pressure, ECG 12 lead, Heart rate (HR), and Heart Rate Variability (HRV). • Biochemical: • Cholesterol, HDL, and triglycerides; • CRP, vWF, Fbg, and cytokines after whole blood stimulation without or with LPS (TNF-α, IL-10); • Sensitivity of leukocytes to inflammatory stimulus; • Cancer biomarkers: anti-oxidant enzymes (GPX, SOD), DNA damage (Comet assay), anti-mutagenic properties of urine (Ames test); • Metabolites of garlic compounds in plasma and urine; • Safety: Parameters of muscle (CPK) and liver function (ALAT), and haematology (haematocrit, WBC count).

  9. Additional measurements suggested in the EU proposal • SAA, and PAI-1 • s-VCAM / s-ICAM / s-Selectine • MCP-1 and other chemokines • Endothelin 1 and 3 • Plasma ox-LDL • Urine isoprostanes

  10. Current study status •  Informed subjects: 120 •  Screened subjects: 70 •  Included (randomized) subjects: 52 •  Subjects started 1st occasion: 43 • # Subjects planned for info: 20 • # Screenings planned: 10 Recruitment is ongoing!

  11. Ackowledgements Martijn van Doorn Koos Burggraaf Sonia Espirito Santo Hans Princen

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