The efficacy of Leucoselect® Phytosome® was assessed at a dosage corresponding to 300 mg/day of procyanidins in four clinical trials. It was proven effective in improving antioxidant defences and in counteracting the oxidative stress, both in normal and in pathological circumstances characterized by an increase in oxidant generation and a decrease in antioxidant protection.
Improvement of the total antioxidant capacity of plasma in healthy volunteers(11)
Leucoselect® Phytosome® was administered for 5 days to 20 young subjects in a single-blind randomized placebo-controlled crossover trial.
The product induced a significant increase of serum total antioxidant capacity (TRAP) assessed on day 1 and day 5, starting already from 30 min postdose with a further increase at 60 min postdose, in comparison with baseline values. After a washout period of at least 2 weeks, the treatment was repeated with similar results.
Antioxidant defenses protect low-density lipoproteins (LDLs) from oxidation by free radicals, a process associated with the initiation of atherosclerosis
Improvement of plasma oxidative status in healthy volunteers after a fatty meal(12)
The capacity of Leucoselect® Phytosome® to prevent the plasma oxidative stress after a fatty meal, rich in lipidic peroxides (“Milanese” steak and French fries), has been evaluated in 8 healthy volunteers. At the beginning of the trial the subjects received the lipidic peroxides rich meal and after a week the same meal and Leucoselect® Phytosome®.
The product was proven able to reduce the oxidative stress induced by the meal, providing a significant reduction of plasma postprandial lipid hydroperoxide concentration with an increase of TRAP and resistance of LDLs to oxidative modification.
Leucoselect® Phytosome® is able to prevent plasma postprandial oxidative stress.
It decreases the oxidants, increases the antioxidant levels in plasma and enhances the resistance of LDLs to oxidative modification.
Reduction of LDL susceptibility to oxidative stress in heavy smokers(13)
Leucoselect® Phytosome® was administered for 4 weeks to 24 healthy male heavy smokers, aged 50 or more, in a randomized double-blind crossover trial. The product induced a significant improvement of LDL resistance to oxidation, as shown by lipid peroxidation parameters: thiobarbituric acid reactive substances concentration (TBARS, an index of lipid peroxidation and oxidative stress) was significantly reduced while the lag phase (an index of LDL resistance to oxidation) was prolonged, both in comparison with placebo and basal values.
Leucoselect® Phytosome® was also endowed with a significant efficacy in what is probably the common model of oxidative stress, namely smoking.
Cigarette smoke contains carbon and oxygen-centered free radicals, which can directly initiate and propagate the process of lipid peroxidation.
Improvement of oxidative stress in diabetic patients(14)
In a double-blinded cross-over parallel study, Leucoselect® Phytosome®was administered for 4 weeks to 24 type-2 diabetic patients, significantly reducing urinary excretion of 8-epi-PGF2α in comparison with placebo. Enhanced urinary excretion of 8-epi-PGF2α is a marker of oxidative stress linked with increased formation of F2 isoprostanes, non enzymatic products of arachidonic acid peroxidation.
Diabetes is a chronic pathological state associated with enhanced lipid peroxidation, microvascular complication, development of atherosclerosis and thromboembolic events