Evidence for effectiveness and functional properties of specialized product in clinical trial

Abstract

Aim. To perform clinical trials aimed to test effectiveness and functional properties of Energiya biologically active additive (BAA) in people exposed to high psychophysiological loads. Materials and Methods. We conducted clinical trials of new formula of Energiya BAA which contains (mg per 1 tablet): peach leaf (extract) - 100; Rhodiola quadrifida (extract) - 75; zinc asparaginate - 45.5; zinc - 8.5; cystine - 30; ascorbic acid - 25; quercetin - 10; rutin - 10; grape seed (extract) - 5; copper asparaginate - 4.4; copper - 0.7; sodium selenite - 0.11; selenium - 0,05; cifrol-5 (antioxidant complex) - 200. Thirty five volunteers were recruited as participants among people regularly exposed to increased psychophysiological loads: physicians, nurses, teachers, and long-haul drivers. Subjects' diet was supplemented with two tablets of the specialized product per day. The control group comprising 35 participants of similar occupations did not receive any bioactive additives. Levels of lipid peroxidation products and free radical activity were assessed based on malondialdehyde concentration. Microcirculatory vascular disturbances were estimated by rheoencephalography. Quality of life was evaluated in accordance with a factor determining health-related restrictions of physical loads; patient-reported data were also used. Results. It was established that supplementing the volunteers' diet with specialized product reduced the levels of lipid peroxidation products and, thus, reversed the symptoms of microcircula-tory disturbances with a simultaneous improvement of quality of life, which could be associated with stabilization of cell membranes and energy metabolism, prevention of oxygen deficiency, and elimination of unfavorable oxidative processes. In the control group such positive changes were not observed. Conclusion. Using BAA Energia as a dietary factor normalizes the microcir-culatory function, contributes to overall rehabilitation, and improves the quality of life affected by high psychophysiological loads.