title: A pilot study on the safety and efficacy of a novel antioxidant rich formulation in patients with cystic fibrosis.
abstract: BACKGROUND
  Pancreatic insufficiency and a diminished bile acid pool cause malabsorption of important essential nutrients and other dietary components in cystic fibrosis (CF). Of particular significance is the malabsorption of fat-soluble antioxidants such as carotenoids, tocopherols and coenzyme Q(10) (CoQ(10)). Despite supplementation, CF patients are often deficient in these compounds, resulting in increased oxidative stress, which may contribute to adverse health effects. This pilot study was designed to evaluate the safety of a novel micellar formulation (CF-1) of fat-soluble nutrients and antioxidants and to determine its efficacy in improving plasma levels of these compounds and reducing inflammatory markers in induced sputum.
  
  
  METHODS
  Ten CF subjects, ages 8 to 45 years old, were given orally 10 ml of the CF-1 formulation daily for 56 days after a 21-day washout period in which subjects stopped supplemental vitamin use except for a standard multivitamin. Plasma obtained at -3, 0 (baseline), 1, 2, 4, and 8 weeks was assayed for beta-carotene, gamma-tocopherol, retinol, and CoQ(10) as well as for safety parameters (comprehensive metabolic panel and complete blood count). In addition, pulmonary function was measured and induced sputum was assayed for markers of inflammation and quantitative bacterial counts both prior and during dosing.
  
  
  RESULTS
  No serious adverse effects, laboratory abnormalities or elevated nutrient levels (above normal) were identified as related to CF-1. Supplementation with CF-1 significantly increased beta-carotene levels at all dosing time points when compared to screening and baseline. In addition, gamma-tocopherol and CoQ(10) significantly increased from baseline in all subjects. Induced sputum myeloperoxidase significantly decreased and there was a trend toward decreases in PMN elastase and total cell counts with CF-1. There was a significant inverse correlation between the antioxidant levels and induced sputum changes in IL-8 and total neutrophils. Lung function and sputum bacterial counts were unchanged.
  
  
  CONCLUSIONS
  The novel CF-1 formulation safely and effectively increased plasma levels of important fat-soluble nutrients and antioxidants. In addition, improvements in antioxidant plasma levels were associated with reductions in airway inflammation in CF patients.
authors.affiliation: Yasoo Health, Johnson City, TN, USA.
authors.forename: Konstantinos A
authors.initials: KA
authors.lastname: Papas
authors.forename: Marci K
authors.initials: MK
authors.lastname: Sontag
authors.forename: Churee
authors.initials: C
authors.lastname: Pardee
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Sokol
authors.forename: Scott D
authors.initials: SD
authors.lastname: Sagel
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Accurso
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Wagener
mesh_terms: D000293:Adolescent; D000328:Adult; D000975:Antioxidants / Q000737:chemistry / Q000493:pharmacokinetics*; D001682:Biological Availability; D002648:Child; D003550:Cystic Fibrosis / Q000150:complications / Q000178:diet therapy*; D019587:Dietary Supplements; D010188:Exocrine Pancreatic Insufficiency / Q000150:complications / Q000178:diet therapy*; D006801:Humans; D016209:Interleukin-8 / Q000378:metabolism; D008823:Micelles; D008875:Middle Aged; D010865:Pilot Projects; D013183:Sputum / Q000166:cytology / Q000187:drug effects / Q000276:immunology; D014451:Ubiquinone / Q000378:metabolism / Q000493:pharmacokinetics; D019207:beta Carotene / Q000378:metabolism / Q000493:pharmacokinetics; D024504:gamma-Tocopherol / Q000378:metabolism / Q000493:pharmacokinetics
chemical_list: D000975:Antioxidants; C508606:CXCL8 protein, human; D016209:Interleukin-8; D008823:Micelles; D019207:beta Carotene; D014451:Ubiquinone; D024504:gamma-Tocopherol