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Cereal Bars Containing SAEF®, a Novel Superhydrating Fiber, Exhibit Significantly Greater Satiety-Enhancing Properties than Cereal Bars Containing Glucomannan in Simulated Stomach Model Hassan M. Heshmati1, MD; Eyal S. Ron1, PhD; Christian Demitri1, PhD; Yishai Zohar1; Alessandro Sannino2, PhD; Tim T. Lambers3, PhD; Ann C. Stijnman3; Hock S. Tan4, PhD. 1 Gelesis, Inc., Boston, MA, USA; 2University of Salento, Lecce, Italy; 3NIZO food research BV, Ede, Netherlands; 4Bionex Pharmaceuticals LLC, North Brunswick, NJ, USA. INTRODUCTION MATERIALS Overweight and obesity are becoming major health problems worldwide (1). Cereal bars containing either 5% SAEF®, 5% glucomannan, or no addition (control) were studied. The therapeutic benefit of all currently available anti-obesity tools is limited by their marginal efficacy and variable tolerability and safety profiles. METHODS The NIZO in vitro simulation of physiological digestion (SIMPHYD) model was used to measure the textural properties of food ingredients under gastrointestinal conditions. The model consists of a glass vessel that has the same size and shape as a typical human stomach, with the same rate of mixing. First, 50 mL of gastric fluid (pH 1.5), 250 mL of water, and 50 g of masticated cereal bars (chewed by human volunteers for 20 sec) are added to the chamber. Next, 200 mL of gastric fluid (pH 7) is added so that a total volume of 500 mL required for optimal functioning of the model is achieved. This step is followed by acidification using HCl. The rate of acidification allows the media to reach a pH of 2 after approximately 50 min which is a typical stomach acidification rate following breakfast (5). Immediately after addition of the gastric fluid, in-line force measurements with the recording of force profiles for a total of 2 h are started. The average value of independent experiments, performed in triplicate, is reported for each cereal bar. Interventions which act mechanically by occupying stomach volume, extending gastric emptying time, and increasing the elastic response and viscosity of the upper gastrointestinal content, could potentially be very beneficial. Dietary fibers have been used for weight management because they possess a number of the properties required to induce satiety (2). In particular, clinical trials have demonstrated that glucomannan causes weight loss (3) and in 2010, the European Food Safety Authority (EFSA) gave a positive scientific opinion, granting glucomannan claims for weight management (4). However, in higher amounts dietary fibers have undesirable gastrointestinal side effects. SAEF® (Satiating Advanced Edible Fiber), a novel hydrogel, is capable of absorbing water up to 100 times its original weight in the stomach and the small intestine environment. SAEF® also increases the elasticity and viscosity of the contents of the small intestine prior to being degraded in the large intestine where it releases the absorbed water (Figure 1). In addition to SIMPHYD model, a Rheometrics Mechanical Spectrometer RS-800 was used for the determination of the rheological properties (elastic modulus and viscosity) of a second similar set of digested cereal bars. OBJECTIVE RESULTS The aim of this study was to assess the characteristics of cereal bars enhanced with SAEF® in comparison to glucomannan or control cereal bars in order to evaluate their potential effect on satiety. SAEF® gel-like particles remained intact even after 2 h of simulated gastric digestion and clearly formed a larger volume. The glucomannan fibers 1 Figure 1. Overview of SAEF® concept Step 1. Step 2. SAEF® is ingested orally before or between meals. After swallowing SAEF®, the subject drinks water. Step 3. Step 4. SAEF® particles absorb water in the stomach. SAEF® particles mix with food and create a larger volume. Step 5. Step 6. SAEF® particles delay gastric emptying and then shrink as the pH of the stomach decreases during digestion. SAEF® particles absorb water in the small intestine, increasing viscosity. Step 7. Step 8. The passage of sugars and fatty acids into the bloodstream is delayed. SAEF® particles degrade in the colon, releasing the absorbed water and passing through the system. 2 Figure 2. Figure 3. Figure 4. Appearance of control cereal bars after 2 h of simulated gastric digestion. Appearance of glucomannanenhanced cereal bars after 2 h of simulated gastric digestion. Appearance of SAEF®-enhanced cereal bars after 2 h of simulated gastric digestion. Figure 5. Figure 6. Force profile of control cereal bars during simulated gastric digestion. Force profile of glucomannan-enhanced cereal bars during simulated gastric digestion. Figure 7. Table 1. Control Glucomannan SAEF® Force profile of SAEF®-enhanced cereal bars during simulated gastric digestion. Rheological measurements of 3 different digested cereal bars. 3 REFERENCES formed aggregates and remained at the bottom of the simulated stomach in contrast to SAEF® particles which did not form aggregates and were dispersed homogenously (Figures 2, 3, 4). Maximum forces observed inside the SIMPHYD stomach model with SAEF® cereal bars were up to 8 times larger than those observed with glucomannan or control cereal bars. Differences started at 7–10 min onwards and lasted up to 2 h with a maximum at 17–33 min (Figures 5, 6, 7). 1. Bessesen DH. Update on obesity. J Clin Endocrinol Metab, 2008, 93, 2027-2034. 2. Papathanasopoulos A, Camilleri M. Dietary fiber supplements: effects in obesity and metabolic syndrome and relationship to gastrointestinal functions. Gastroenterology, 2010, 138, 65–72. 3. Sood N, Baker WL, Coleman CI. Effect of glucomannan on plasma lipid and glucose concentrations, body weight, and blood pressure: systematic review and meta-analysis. Am J Clin Nutr, 2008, 88, 1167–1175. SAEF®-enhanced cereal bars also displayed significantly higher elastic modulus and viscosity than glucomannan-enhanced cereal bars in the Rheometrics Mechanical Spectrometer (Table 1). 4. Agostoni CV. EFSA Journal, 2010, 8, 1798. These results are consistent with previously reported data, showing the superior rheological properties of neat SAEF® compared to other fibers, including glucomannan (6). 5. Simonian HP, Vo L, Doma S, Fisher RS, Parkman HP. Regional postprandial differences in pH within the stomach and gastroesophageal junction. Dig Dis Sci, 2005, 50, 2276–2285. CONCLUSION 6. Demitri C, Marotta F, Sannino A, Ron ES, Zohar Y, Ambrosio L. Rheological and mechanical comparison between dietary fibers and a novel superabsorbent biodegradable hydrogel (SAEF®). In: Program of the 24th Annual Conference of the European Society for Biomaterials, September 4–8, 2011; Dublin, Ireland. Abstract #643. Cereal bars containing SAEF have better textural properties and significantly greater elasticity and viscosity after digestion than the other tested cereal bars. These two properties are known to enhance satiety. ® Through its advanced properties, SAEF® could be a promising new approach for weight management by inducing prolonged satiety. The content of this document was presented in a Poster at Obesity 2011, 29th Annual Scientific Meeting, Orlando, Florida, October 1–5, 2011. 4