Safety assessment of a soluble dietary fiber, isomaltodextrin, enzymatically produced from starch

Abstract

-A series of safety studies were conducted using isomaltodextrin (IMD), a new dietary fiber that is produced from starch using enzymes. IMD consists of only alpha linkaged glucose molecules, has an average molecular weight of approximately 5,000, is freely soluble in water, and contains greater than 80% fiber (AOAC 2001.03). No genotoxicity was observed when IMD was assayed in standardized bacterial reverse mutation, micronucleus, and chromosome aberration tests. The LD 50 of IMD was found to be more than 2,000 mg/kg in an acute toxicity study in rats, and the no observed adverse effect level (NOAEL) was determined to be 1,000 mg/kg/day in a 90-day subacute gavage toxicity study in rats. No animals died, and no abnormal findings due to consumption of IMD were observed in either of these studies. Both NOAEL values were the highest doses tested. The NOAEL for loose stools was examined in humans in two separate studies. Based on these results, the NOAEL for IMD-related loose stools was considered to be 0.8 g/kg-BW. In a 4-week high-dose ingestion study in humans and a 12-week low-dose ingestion study in humans, laboratory values were found to be within the normal range of variation. The results of the current safety assessment studies suggest that isomaltodextrin is safe for human consumption.

Quality Evaluation, Storage Stability, and Sensory Characteristics of Wheat Noodles Incorporated with Isomaltodextrin

“…In 2016, isomaltodextrin was assessed as a food that is generally recognized as safe (GRAS) by the US Food and Drug Administration (FDA) [ 7 ]. Isomaltodextrin presented health effects such as inhibition of fat absorption [ 8 ], anti-inflammatory properties, reduced risk of developing insulin resistance and associated metabolic diseases [ 9 ], diminished postprandial blood glucose [ 10 ], positive effects on intestinal flora [ 11 ], and inhibition of hen egg ovalbumin allergic response by inducing immune tolerance in mice [ 12 ].…”

Isomaltodextrin strengthens model starch gels and moderately promotes starch retrogradation

“…IMD consists of solely glucose residues connected by approximately 49% α‐1,6 glucosidic linkages, 19% α‐1,4 glucosidic linkages, 17% α‐1 non‐reducing end‐group glucosidic linkages, 3% α‐1,3 glucosidic linkages for the linear part, 7% α‐1,3,6 glucosidic linkages and 5% α‐1,4,6 glucosidic linkages at the branch points, and in addition, it contains more than 80% dietary fibre on a dry basis (Tsusaki et al ., 2009). IMD has been reported to slightly inhibit maltase and isomaltase activities in vitro and to attenuate postprandial blood glucose in humans when consumed after maltodextrin, sucrose or glucose (Sadakiyo et al ., 2017a). Therefore, IMD is a promising material to decrease postprandial blood glucose level when incorporated into a food product rich in rapidly digestible starch, and thus, it potentially has applications as a source of dietary fibre.…”

Safety assessment of isomaltodextrin-producing enzymes from <i>Paenibacillus alginolyticus</i>

“…Accordingly, IMD is expected to be applicable for wide-spread use in foods as a new soluble dietary fiber. Various studies have been conducted to evaluate the safety of IMD, including acute toxicity studies, 90-day repeated oral-dose toxicity studies, genotoxicity studies, and studies to determine the no observed adverse effect level (NOAEL) for loose stools; all of these reports have found that IMD is a highly safe substance (Sadakiyo et al, 2017). Moreover, IMD has been evaluated as a food that is generally recognized as safe (GRAS) by experts in the United States of America, and GRAS certification was obtained from the U.S. Food and Drug Administration (FDA) on June 6, 2016.…”