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EUGIS. European Union Garlic Inflammation Study in Humans. Background. No clear indications that ‘garlic’ influences lipid metabolism Indications from cell and animal studies that ‘garlic’ may influence inflammation parameters

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eugis

EUGIS

European Union Garlic Inflammation Study in Humans

background

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
slide3
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
inclusion criteria
Inclusion criteria
  • Able and willing to give informed consent
  • 90 subjects of either gender*
  • Aged between 40-75 years
  • Smoking≥ 10 cigarettes/day and BMI≥ 24.5 kg/m2

* 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

e xclusion criteria
Exclusion criteria
  • Any major clinical significant abnormality detected by a general health questionnaire or by blood sampling
  • Chronic drug treatment /use of medication
  • Participation in prior study in the last 3 months or blood donation
  • Inadequate use of contraceptives / pregnancy / lactating women
  • History of alcohol / drug abuse
  • Positive test results for HepB/C or HIV
  • Dislike of garlic
experimental design

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

12 weeks treatment
12-weeks treatment
  • 1. Garlic (from EU-sponsored Printanor 2001)
    • Lichtwer capsule preparation (300 mg)
    • 2.1g daily (3 cap - breakfast & 4 cap at dinner)
  • 2. Atorvastatin:
    • 40 mg/day daily at dinner
  • 3. Placebo:
    • garlic and statin placebo daily
measurements
Measurements
  • Safety:
    • Parameters of muscle and liver function
    • Haematology
  • Clinical:
    • Blood pressure
    • 12 lead ECG (HR, conduction)
    • Heart Rate Variability (HRV)
measurements1
Measurements
  • 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;
additional measurements suggested in the eu proposal

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
current study status
Current study status
  •  Subjects at information sessions: >148
  •  Subjects signing IC: 142
  •  Subjects randomised : 92
    •  Subjects completed: 84
    •  Subjects withdrawn: 8 (6 non-related AEs)
  • Entire clinical study period: < 5 months!
    • last samples at Jan 15th
study population baseline
Study population - baseline
  • Female
    • n = 47
    • age: 40-67 yrs
    • BMI: 29.6 (SD: 4.1) kg/m2
    • BP: 124 (18) / 76 (12) mm Hg
  • Male
    • n = 37
    • age: 40-63 yrs
    • BMI: 29.3 (SD: 3.2) kg/m2
    • BP: 130 (11) / 82 (10) mm Hg
baseline lipids
Baseline lipids
  • Female
    • Total Cholesterol: 5.60 (1.01) mmol/L (3.9-7.3)
    • HDL-Cholesterol: 1.35 (0.32) mmol/L (>1.16)
    • LDL-Cholesterol: 3.52 (0.95) mmol/L
    • Triglycerides: 1.63 (0.95) mmol/L(0.8-1.94)
  • Male
    • Total Cholesterol: 5.71 (1.04) mmol/L (3.9-7.3)
    • HDL-Cholesterol: 1.11 (0.32) mmol/L (>0.90)
    • LDL-Cholesterol: 3.54 (0.99) mmol/L
    • Triglycerides: 2.35 (1.32) mmol/L(0.8-1.94)
adverse events
Adverse Events
  • AE’s
    • Headache:
      • 52 episodes in 41 subjects
    • Abdominal discomfort
      • 36 episodes in 26 subjects
    • Other
      • 60 various events (URT infection, ‘pains’, intercurrents)
slide15

PLAN

  • All samples have been / are being shipped
  • Unblinding next week
  • Primary parameter laboratory analysis completed at Jan 31st
  • Stats analysis time allocated
  • Main report around March 1st 2004
  • Additional reports: to be discussed
slide16

THANKS

  • Lichtwer
    • S Striegl
    • T Haffner
  • LUMC pharmacy
    • R Press
  • TNO-PG
    • P Meijer
    • R Kret
    • R Streunding
  • CHDR
    • M van Doorn
    • I Kamerling
    • Nursing staff
  • Participants who tolerated 2.1 gram garlic/day