Effect of Oral Lipid Matrix Supplement on Fat Absorption in Cystic Fibrosis
A Randomized Placebo-Controlled Trial
Virginia A. Stallings
Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia
Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia
Search for more papers by this authorCorresponding Author
Joan I. Schall
Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia
Address correspondence and reprint requests to Joan I. Schall, PhD, The Children's Hospital of Philadelphia, 3535 Market St, Rm 1554, Philadelphia, PA 19104 (e-mail: [email protected]).Search for more papers by this authorAsim Maqbool
Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia
Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia
Search for more papers by this authorMaria R. Mascarenhas
Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia
Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia
Search for more papers by this authorBelal N. Alshaikh
Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia
Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
Search for more papers by this authorKelly A. Dougherty
Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia
Stockton University, Pomona, NJ
Search for more papers by this authorKevin Hommel
Center for Adherence and Self-Management, Cincinnati Children's Hospital Medical Center
Department of Pediatrics, Division of Behavioral Medicine and Clinical Psychology, University of Cincinnati College of Medicine, Cincinnati, OH
Search for more papers by this authorJamie Ryan
Center for Adherence and Self-Management, Cincinnati Children's Hospital Medical Center
Department of Pediatrics, Division of Behavioral Medicine and Clinical Psychology, University of Cincinnati College of Medicine, Cincinnati, OH
Search for more papers by this authorOkan U. Elci
Westat Biostatistics and Data Management Core, Children's Hospital of Philadelphia, Philadelphia, PA
Search for more papers by this authorVirginia A. Stallings
Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia
Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia
Search for more papers by this authorCorresponding Author
Joan I. Schall
Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia
Address correspondence and reprint requests to Joan I. Schall, PhD, The Children's Hospital of Philadelphia, 3535 Market St, Rm 1554, Philadelphia, PA 19104 (e-mail: [email protected]).Search for more papers by this authorAsim Maqbool
Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia
Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia
Search for more papers by this authorMaria R. Mascarenhas
Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia
Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia
Search for more papers by this authorBelal N. Alshaikh
Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia
Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
Search for more papers by this authorKelly A. Dougherty
Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia
Stockton University, Pomona, NJ
Search for more papers by this authorKevin Hommel
Center for Adherence and Self-Management, Cincinnati Children's Hospital Medical Center
Department of Pediatrics, Division of Behavioral Medicine and Clinical Psychology, University of Cincinnati College of Medicine, Cincinnati, OH
Search for more papers by this authorJamie Ryan
Center for Adherence and Self-Management, Cincinnati Children's Hospital Medical Center
Department of Pediatrics, Division of Behavioral Medicine and Clinical Psychology, University of Cincinnati College of Medicine, Cincinnati, OH
Search for more papers by this authorOkan U. Elci
Westat Biostatistics and Data Management Core, Children's Hospital of Philadelphia, Philadelphia, PA
Search for more papers by this authorSupplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal's Web site (www.jpgn.org).
www.clinicaltrials.gov registration number: NCT00406536 (Study of LYM-X-SORB to Improve Fatty Acid and Choline Status in Children with Cystic Fibrosis and Pancreatic Insufficiency).
This study was supported by National Institute of Diabetes and Digestive and Kidney Diseases (R44DK060302) and the Nutrition Center at the Children's Hospital of Philadelphia. The project described was supported by the National Center for Research Resources, grant UL1RR024134, and is now at the National Center for Advancing Translational Sciences, grant UL1TR000003. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
W.A.S., President of Avanti Polar Lipids, Inc, was the principal investigator of the NIH Small Business Innovation Research award. The other authors report no conflicts of interest.
ABSTRACT
Pancreatic enzyme therapy does not normalize dietary fat absorption in patients with cystic fibrosis and pancreatic insufficiency. Efficacy of LYM-X-SORB (LXS), an easily absorbable lipid matrix that enhances fat absorption, was evaluated in a 12-month randomized, double-blinded, placebo-controlled trial with plasma fatty acids (FA) and coefficient of fat absorption (CFA) outcomes. A total of 110 subjects (age 10.4 ± 3.0 years) were randomized. Total FA increased with LXS at 3 and 12 months (+1.58, +1.14 mmol/L) and not with placebo (P = 0.046). With LXS, linoleic acid (LA) increased at 3 and 12 months (+298, +175 nmol/mL, P ⩽ 0.046), with a 6% increase in CFA (P < 0.01). LA increase was significant in LXS versus placebo (445 vs 42 nmol/mL, P = 0.038). Increased FA and LA predicted increased body mass index Z scores. In summary, the LXS treatment improved dietary fat absorption compared with placebo as indicated by plasma FA and LA and was associated with better growth status.
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