RESUMEN
Aims: To examine the efficacy of a weight loss strategy using a high-protein formula diet in combination with a lipid adsorbing fibre, polyglucosamine, over 12 weeks. Study Design: Randomised, double-blind, placebo-controlled, parallel group study. Place and Duration of Study: Institute of Food Science, Unit of Nutrition Physiology and Human Nutrition, Leibniz University of Hannover, Germany, between February 2010 and July 2010. Methodology: 120 overweight and obese subjects participated in this study and ingested a protein-rich formula diet as a meal replacement once daily. Half of the participants (n = 60) additionally took two lipid-adsorbent tablets (F+LA), polyglucosamine, once daily, while the other half (n = 60) received two placebo tablets (F+P). Measurements were taken at weeks 0, 6 and 12 to determine the response to intervention. Results: Both groups achieved a highly significant (P < 0.001) weight loss (F+LA: -5.5 ± 3.8 kg vs. F+P: -4.7 ± 3.9 kg, Full Analysis Set (FAS) population). There was a significant decrease in HbA1c (P < 0.01), total cholesterol (P < 0.001), LDL cholesterol (P = 0.002), and triacylglycerol (P = 0.001) in the F+LA group, while the F+P group experienced no changes. Conclusion: The investigation demonstrated that a formula diet alone or combined with polyglucosamine were both effective in weight reduction. The additional administration of polyglucosamine was more effective on the reduction of glucose and lipid parameters than the formula diet alone.