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European Union Garlic Inflammation Study (EUGIS)

European Union Garlic Inflammation Study (EUGIS). History Garlic would influence lipid metabolism / atherosclerosis Proposed study: - 2 x 24 apparently healthy subjects with increased risk (mildly hypercholesterolemic, smoking) - parallel trial (24 garlic / 24 placebo)

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European Union Garlic Inflammation Study (EUGIS)

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  1. European Union Garlic Inflammation Study (EUGIS) • History • Garlic would influence lipid metabolism / atherosclerosis • Proposed study: • - 2 x 24 apparently healthy subjects with increased risk (mildly hypercholesterolemic, smoking) • - parallel trial (24 garlic / 24 placebo) • - biochemical measures lipid metabolism / inflammation

  2. European Union Garlic Inflammation Study (EUGIS) • Current situation: • No indications that ‘garlic’ influences lipid metabolism • Human intervention study without rationale is unethical; previous proposal not feasible • New situation requires evaluation; other type of intervention study

  3. European Union Garlic Inflammation Study (EUGIS) • Considerations: • 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 (for example: lipid lowering drugs; statins)

  4. European Union Garlic Inflammation Study (EUGIS) • Primary endpoint: C-reactive protein • Secondary efficacy parameters: • fibrinogen, vWF, sensitivity of leukocytes to inflammatory stimulus • plasma lipids • blood pressure • cancer biomarkers (anti-oxidant enzymes, DNA damage, antimutagenic properties) • metabolites

  5. European Union Garlic Inflammation Study (EUGIS) • Double dummy placebo-controlled trial; 3 parallel groups (n=30); risk group (40-75 y,BMI  24.5 kg/m2, smoking  10 cig/d, post-menopausal) • Spanish Printanor 2001 2.1g/day • Statin 40 mg/day • Placebo • Power = 0.87- 0.72 for 30 - 25% CRP-reduction

  6. European Union Garlic Inflammation Study (EUGIS) • Garlic powder from EU-sponsored breeding programme, Spanish Printanor year 2001 • - all compounds present in fresh garlic / sulphur-rich compounds preserved (allicin content 1.02%) • - compliant with European Pharmacopoeae with respect to microbial impurities • - heavy metals, pesticides, aflatoxin comply

  7. European Union Garlic Inflammation Study (EUGIS) • Recruitment: advertisements • Medical screening + blood sampling • Randomisation • Duplicate sampling (10-14 days apart) / measurements at start, after 4 wks and at end treatment period (12 wks)

  8. European Union Garlic Inflammation Study (EUGIS) Screening Intervention period 11-12 weeks -2 0 4 - 5 Blood and urine collection

  9. European Union Garlic Inflammation Study (EUGIS) • Biomarkers for inflammation • C-Reactive Protein • Fibrinogen • Cytokines after whole blood stimulation without and with LPS (TNF- or IL-10) • von Willebrand Factor (biomarker for endothelial function)

  10. European Union Garlic Inflammation Study (EUGIS) • Clinical measures (ECG, HRV, BP) • Routine lab (cholesterol, HDL-C, triglycerides, Hb, haematocrit, white cell count, liver/kidney/ muscle function) • DNA damage in lymphocytes (comet assay) • Anti-oxidant enzymes (GPX, SOD) • Antimutagenic properties of urine (Ames test) • Metabolites of garlic compounds in plasma and urine

  11. European Union Garlic Inflammation Study (EUGIS) • Additional biomarkers (suggested (in the EU-proposal)) • s-VCAM / s-ICAM / s-Selectine • PAI-1 • MCP-1 and other chemokines • endothelin 1 and 3 • SAA • ox-LDL (plasma) / isoprostanes (urine) • soluble CD40L (platelets)

  12. European Union Garlic Inflammation Study (EUGIS) • Points to discuss • Positive control (is statin the right control?; preparation placebo; costs) • Mask taste/smell (DADS in placebo?) • If bad compliance, reduce dosage to 1.2 g/d • Costs working up blood/lymphocytes • Further characterisation of garlic powder • Additional measurements and financing

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