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Purpose: To evaluate the effect of adding tomato extract to the treatment regime of moderate hypertensives with uncontrolled blood pressure (BP) levels.

Methods: Fifty four subjects with moderate HT treated with one or two antihypertensive drugs were recruited and 50 entered two double blind cross-over treatment periods of 6 weeks each, with standardized tomato extract or identical placebo. Plasma concentrations of lycopene, nitrite and nitrate were measured and correlated with BP changes.

Results: There was a significant reduction of systolic BP after 6 weeks of tomato extract supplementation, from 145.8 /- 8.7 to 132.2 /- 8.6 mmHg (p < 0.001) and 140.4 /- 13.3 to 128.7 /- 10.4 mmHg (p < 0.001) in the two groups accordingly. Similarly, there was a decline in diastolic BP from 82.1 /- 7.2 to 77.9 /- 6.8 mmHg (p = 0.001) and from 80.1 /- 7.9 to 74.2 /- 8.5 mmHg (p = 0.001). There was no significant change in systolic and diastolic BP during the placebo period. Serum lycopene level increased from 0.11 /- 0.09 at baseline, to 0.30 /- 01.3 [mu]mol/L after tomato extract therapy (p < 0.001). There was a significant correlation between systolic BP and lycopene levels (r = -0.49, p < 0.001).

Conclusions: Tomato extract when added to patients treated with low doses of ACE inhibition, calcium channel blockers or their combination with low dose diuretics, had a clinically significant effect-reduction of BP by more than 10 mmHg systolic and more than 5 mmHg diastolic pressure. No side-effects to treatment were recorded and the compliance with treatment was high. The significant correlation between systolic blood pressure values and level of lycopene suggest the possibility of cause-effect relationships.

(C)2009 Kluwer Academic Publishers