Phase II 2006-2011:
The NIH, National Diabetes and Digestive and Kidney Disease Division awarded funding, for this application (2R44 DK060302-02A1 entitled Organized Lipid Matrix: Fatty Acids and Choline in Cystic Fibrosis). This six million dollar study conducted a randomized placebo-controlled double-blinded study to evaluate the effectiveness of the next generation Lym-X-Sorb® with improved palatability and mixing characteristics on fatty acid and choline status of 78 children, ages 6.0 to 17.9 years, with Cystic Fibrosis (CF) and pancreatic insufficiency (PI). The study also explored whether Lym-X-Sorb® supplementation will improve fat soluble vitamin status, bile composition, incidence of fatty liver, inflammatory cytokines, resting energy expenditure and respiratory quotient over 12 months and improve pulmonary function, growth status, body composition and overall health status over 18 months. Participants in this study were Walter Shaw, Ph.D. (Avanti Polar Lipids, Inc.), Virginia Stallings, MD (Children's Hospital of Philadelphia) and David Yesair, Ph.D. (LYM-MED NUTRITIONAL PRODUCTS, LLC). The data collection ended in June 2011 with report to follow.
Two abstracts were presented at the October 20-23, 2011 North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition Annual Meeting.
CF: EFFECT OF CHOLINE SUPPLEMENTATION ON MUSCLE.
Methods: Subjects with CF & PI took part in a double-blind randomized placebo-controlled supplementation trial of LYM-X-SORB®.
Conclusion: Muscle choline content was 1)lower at baseline in CF subjects compared to controls; 2) increased after 12 months of LYM-X-SORB® supplements in CF subjects; 3) was associated with better growth status. Daily choline supplements can improve choline status.
SERUM AMINO ACID PROFILES IN CHILDREN WITH CF RECEIVING SUPPLEMENTAL CALORIES, FAT AND CHOLINE
Objectives: To describe changes in AA profiles in children with CF & PI receiving 18 mo. of daily supplementation with LYM-X-SORB® (LXS®), an organized lipid matrix with choline and fatty acids v. a placebo with similar calorie & fat content, but 1/8th the choline.
Conclusions: Supplementation with extra calories & fat for 18 mo. decreased serum AAA and improved BCAA:AAA in subjects with CF, suggesting improved hepatic protein metabolism. The additional choline did not result in further changes to the AA profile.
In order to evaluate the extent of absorption of 13C-labeled LYM or triglyceride, a crossover design was conducted in subjects with CF and healthy volunteers [SBIR Phase I: 1 R43 OK 48208-01, Guy Lepage, PhD, Claude Roy, MD, of Hopital Sainte Justine, Pediatric Research Center, Universite of Montreal, Montreal (Quebec) Canada, and David W. Yesair, PhD BioMolecular Products, Inc. Byfield MA. Decreased respiratory excretion rates of 13CO2 without enzyme supplementation, indicate fat malabsorption. In the absence of pancreatic enzyme medication, the subjects with CF poorly absorbed 13C- labeled triglycerides. However, in the 13C-labeled Lym-X-Sorb® subjects with CF and healthy subjects had equivalent absorption, which was similar to 13-labeled triglycerides in healthy subjects. Thus, Lym-X-Sorb® represents a readily absorbable lipid matrix.
In a crossover design study and in the absence of pancreatic enzyme supplements, the acute oral absorption of Lym-X-Sorb® supplemented with added retinyl palmitate, was compared to that of Scandishake® with added retinyl palmitate (Guy Lepage, PhD, Claude Roy, MD, of Hopital Sainte Justine, Pediatric Research Center, Universite of Montreal, Montreal (Quebec) Canada) (J. Pediatr. 2002;141:178-85). Approximately 29 g/m2 of body surface area of Lym-X-Sorb® or triglyceride (Scandishake®) and 48,000 I.U./m2 of body surface area of retinyl palmitate were orally consumed at time zero. In five subjects with CF and three controls (all fasted overnight), plasma triglyceride peaked at approximately 2 hours (Cmax) and decreased thereafter until 12 h (area under curve, AUC). Both Cmax and AUC for the LYM supplement were statistically greater by 10-fold than the corresponding values following the ingestion of Scandishake®. Similar 10 fold differences were observed for the absorption of retinyl palmitate. Again, LYM was shown to be a readily absorbable lipid matrix that enhances the absorption of fat-soluble retinyl palmitate.
In a one year double blind feeding study (Guy Lepage, PhD, Claude Roy, MD, of Hôpital Sainte Justine, Pediatric Research Center, Université of Montréal, Montréal (Québec) Canada, 1998-2001) (J. Pediatr. 2002;141:178-85), the daily consumption of Lym-X-Sorb® in comparison to triglyceride (24g of lipid per 1.72 m2 of body surface) by subjects with CF (who also consumed, daily pancreatic enzyme supplement) had improved the clinical outcome. The Lym-X-Sorb and triglyceride formulations contained at least 50% polyunsaturated fatty acid with a mole ratio of linolenic and a-linolenic fatty acids of about 5:1. Lym-X-Sorb® contained about 20% (w/w) lysophosphatidylcholine. Per protocol analysis of 48 subjects showed the Lym-X-Sorb® produced better clinical outcomes in comparison to triglyceride supplements as follows:
- Increased energy intake (-10%) from diet (P 0.002)
- Increased plasma levels of linoleic acid (P <0.001) and a-linolenic acid (P <0.01)
- Increased plasma levels of vitamin E (P <0.001) and retinal-binding protein (P = 0.02)
- Increased growth in terms of weight (P <0.05) and height (P = 0.03) Z scores
- Improved lung function: FEV1 (P 0.02) and PE max (P = 0.02)
Liver and other clinical biochemistry did not change in the subjects. In conclusion, the readily absorbable Lym-X-Sorb was an effective and safe medical food.