A pilot study on the safety and efficacy of a novel antioxidant rich formulation in patients with cystic fibrosis
Received 9 January 2007; received in revised form 23 April 2007; accepted 25 April 2007.
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 Q10 (CoQ10). 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 β-carotene, γ-tocopherol, retinol, and CoQ10 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 β-carotene levels at all dosing time points when compared to screening and baseline. In addition, γ-tocopherol and CoQ10 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.
Conclusion
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.
aDepartment of Pediatrics, University of Colorado Health Sciences Center, Mike McMorris Cystic Fibrosis Center, The Children's Hospital, Denver, Colorado, USA
bDepartment of Preventive Medicine and Biometrics, University of Colorado at Denver and Health Sciences Center, Colorado, USA
ABSTRACT