title: Neuroprotective impact of a vitamin trace element composition - a randomized, double blind, placebo controlled clinical trial with healthy volunteers.
abstract: OBJECTIVE
  Neurotoxic metabolites and oxidative and nitrosative stress reactions play a crucial role in the pathways leading to neuronal cell death and neurodegeneration. The bioavailability of the many antioxidant ingredients a vitamin and trace element composition was investigated, to reveal the neuroprotective (preventive) potential of the composition.
  
  
  METHODS
  We recruited 159 healthy volunteers, assigned them randomly and double blind to a placebo and verum group. Physicians excluded volunteers with severe chronic diseases or interfeering medications. 142 participants finished the six month trial. Laboratory parameters were determined 1) before participation, and 2) after three and 3) six months. We confirmed the bioavailability of ingredients, and determined metabolic parameters associated with the integrity of the blood brain barrier, mitochondrial deficiency (Q 10), neurodegeneration (homocystein), and antioxidative capacity (e.g. lipidperoxidation), and superoxiddismutase activity.
  
  
  RESULTS
  Starting from baseleine, after three months neuroprotective ingredients increased within their physiological borders, folic acid (p<0.003), pyridoxin (p<0.001), cobalamin (p=0.001), and the fat soluble vitamin tocopherol (p<0.001). In parallel, homocytein decreased after 3 and 6 months (p<0.001, and p<0.025, respectively). Other paramters like zinc reacted slower, significant changes were observed only after 6 months.
  
  
  CONCLUSIONS
  The observed metabolic changes and alteration of the oxidative status after 3 and six month of regular intake underlines the compositions' potential to ameliorate neurodegenerative processes. We conclude that the subsitution of vitamins and trace-elements with natural source in a proper manner may be effective for neuroprotection in healthy population.
authors: Internationale Gesellschaft für angewandte Präventionsmedizin I-GAP, Währingerstrasse 63, A-1090 Wien, Austria, Austria.
authors: Claus
authors: C
authors: Muss
authors: Inst. f. Krebsforschung, KIM-1, Medizinische Universität A-1090 Wien, Austria.
authors: Wilhelm
authors: W
authors: Mosgoeller
authors: Labor Endler, Währingerstrasse 63, A-1090 Wien, Austria.
authors: Thomas
authors: T
authors: Endler
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005492:Folic Acid / Q000378:metabolism; D064368:Healthy Volunteers; D006710:Homocysteine / Q000378:metabolism*; D006801:Humans; D015227:Lipid Peroxidation / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000008:administration & dosage / Q000378:metabolism*; D011736:Pyridoxine / Q000378:metabolism; D013482:Superoxide Dismutase / Q000378:metabolism*; D024505:Tocopherols / Q000378:metabolism; D014131:Trace Elements / Q000008:administration & dosage / Q000378:metabolism*; D014805:Vitamin B 12 / Q000378:metabolism; D014815:Vitamins / Q000378:metabolism*
chemical_list: D018696:Neuroprotective Agents; D014131:Trace Elements; D014815:Vitamins; D006710:Homocysteine; D005492:Folic Acid; D013482:Superoxide Dismutase; D011736:Pyridoxine; D014805:Vitamin B 12; D024505:Tocopherols