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Fibersol-2 resistant Maltodextrin: Functional Dietary Fiber Ingredient

Chieko Hashizume and Kazuhiro Okuma

CONTENTS Introduction ........................................................................................................... 61 What Is Resistant Maltodextrin?.........................................................................63 Physiological Effects of Resistant Maltodextrin ...............................................64 Gastrointestinal Functions .........................................................................64 Beneficial Effects on Bowel Movement .........................................65 Improvement in Intestinal Environments ....................................65 Attenuation of Postprandial Blood Glucose Levels ................................ 69 Improvement in Sugar and Fat Metabolism by Repeated IngestionDecreases in Total Cholesterol and Triglyceride Levels ........................................................................... 70 Decreases in Body Fat Ratio ....................................................................... 71 Safety and Food Applications ............................................................................. 72 Safety ............................................................................................................ 72 Food Applications ........................................................................................ 74 Measuring Method of Total Dietary Fiber in Foods Containing Resistant Maltodextrin ................................................................................ 75 References ..............................................................................................................77

Introduction
Dietary fiber is considered an essential nutrient in Japan based on continued research showing the health benefits of daily consumption along with the essential amino acids, essential fatty acids, vitamins, and minerals. The functions of dietary fiber are essential and of equal importance to the benefits of other essential nutrients. The beneficial effects of diets rich in dietary fiber include decreased risk of coronary heart disease and improvement in
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40 35 30 DF Intake (g/day) 25 20 15 10 5 0

Fiber Ingredients: Food Applications and Health Benefits

Adequate Intake

Actual Intake

Actual I for males Actual I for females Adequate I for males Adequate I for females

1 3

4 8

1 8

3 0

5 0

9 13

7 0 51

14

19

(Age, years old) FIGuRe 5.1 Dietary fiber intake of U.S. population: the gap between the actual intake and the adequate intake (AI). : actual intake amount of dietary fiber for males, : actual intake amount of dietary fiber for females, : adequate intake amount of dietary fiber suggested for males, : adequate intake amount of dietary fiber suggested for females. (Adapted from Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Food and Nutrition Board, Institute of Medicine, National Academies, 2005.)

intestinal regularity. The research behind a possible relationship between fiber-rich diets and a lower risk of type 2 diabetes shows potential. Although the importance of dietary fiber is well recognized, the actual intake of dietary fiber is declining. The Dietary Guidelines for Americans (2005) attributes this decline in dietary fiber intake to a lower consumption of whole grain foods, fruits, and vegetables. The problem is compounded by the lack of many foods that contain whole grains. While the recommended dietary fiber intake for Americans is 14 grams per 1000 calories (approximately 38 and 25 grams per day for men and women respectively), the average dietary fiber intake among Americans is only about half these recommended amounts (Figure 5.1). Dietary fiber consumption among almost all industrialized countries is less than 20 grams per day. Changes in lifestyles, especially the increasing habit of eating processed foods or ready-to-eat meals, are also a contributing factor for the lower dietary fiber intake than the recommended intake. In order to increase the consumption of dietary fiber and fill the gap between the current intake and the recommended intake, it appears prudent to add more dietary fiber to processed foods. Japanese scientists have developed various types of low-molecular-weight soluble dietary fibers and oligosaccharides to fill the fiber gap. One outstanding fiber product is Fibersol-2, a resistant maltodextrin product developed and registered by Matsutani Chemical Industry Co., Ltd., Itami, Hyogo,

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Fibersol-2 resistant Maltodextrin: Functional Dietary Fiber Ingredient

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Japan. The resistant maltodextrin has the following physiological properties associated with dietary fiber: (1) improvement of intestinal regularity; (2) moderation of postprandial blood glucose levels; and (3) the reduction of serum cholesterol and triglyceride levels.

What Is Resistant Maltodextrin?

Fibersol-2 is prepared from moistened Starch (corn, etc.) starch (corn, tapioca, etc.) by heating to 140C 160C with a trace amount of acid Dextrinization with acid at 140160C (Moistened powdery starch) (Figure 5.2). During this most characteristic stage in the production process, Hydrolysis with amylases both hydrolysis and transglucosidation of Removal of glucose by ltration starch occur (dextrinization process). The resulting dextrin solution is hydrolyzed Decolorization by active carbon by enzymes, before being refined by filDeionization by ion-exchange resin tration through activated carbon and an ion-exchange resin. After concentration, Concentration and spray-drying the non-digestible material is spray-dried. Weighing and packaging The final product is stable to any further hydrolysis by heat, acid, and/or enzymes, Resistant Maltodextrin Product including the conditions found in the human digestive system. These proper- FIGuRe 5.2 ties greatly contribute to its functionality Manufacturing process of resistant and acceptance in food systems and food maltodextrins. products. The resistant maltodextrin consists of a small ratio of saccharides that have the degree of polymerization (DP) 19, and a large amount of polysaccharides with a DP 10 or more. It has a typical carbohydrate composition of ~10 DE maltodextrin, with the average molecular weight of 2000. In 1990, the Matsutani Company obtained a letter of compliance from the U.S. Food and Drug Administration confirming that Fibersol-2 meets the requirements for the GRAS status set forth in 21 CFR 184.1444 Maltodextrin. Therefore, it is officially recognized as a maltodextrin under the U.S. regulation. The glucosidic linkages and the molecular structure model of the resistant maltodextrin are illustrated in Figure 5.3. The resistant maltodextrin has a higher amount of 1-6 linkage than conventional maltodextrin of the same DE. Resistant maltodextrin not only has 1-4 and 1-6 linkages that are found in starch, but also contains 1-2 and 1-3 linkages, which are formed during the dextrinization process. The properties described above contribute to allow resistant maltodextrin to be approximately 10% digested and absorbed in the small intestine. Approximately 50% is fermented in the large intestine and the remaining approximate

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CH2OH O OH

Fiber Ingredients: Food Applications and Health Benefits

CH2OH O OH OCH2 O OH OH O O

HO

CH2OH OH O OH O OH

CH2 OH O

HO

CH2OH O OH OH CH2OH O OH

HO

OH CH2OH O OH OH

O OH CH2OH CH2OH O O O OH OH O O OH OH O

OH CH2OH O OH

O OH CH2OH O O OH OH

CH2OH O OH

CH2O

O OH

Chemical structure model of Fibersol -2 Glucosidic linkage Conventional maltodextrin -Enzymatic hydrolysis -Acidic hydrolysis Fibersol -2 94.7% 91.6% 58.5% 4.5% 5.1% 27.0% 0.0% 1.2% 3.2% 0.9% 2.2% 11.3% 1 4 1 6 1 2 1 3

FIGuRe 5.3 Structural characteristics of resistant maltodextrin: comparison with conventional maltodextrins prepared by enzymatic or acid hydrolysis. (Adapted from Okuma, K. and Matsuda, I., J. Appl. Glycosci., 49, 479485, 2002.)

40% is excreted into the feces [1]. Therefore, the maltodextrin is distinguished from conventional digestible maltodextrin and the scientific categorization as digestion-resistant maltodextrin or indigestible dextrin.

Physiological Effects of Resistant Maltodextrin

Gastrointestinal Functions As 90% of the resistant maltodextrin reaches the large intestine and 50% is fermented, these findings support and contribute to its physiological effects in the large intestine. The beneficial effects of Fibersol-2 as a typical soluble dietary fiber are summarized in the following.

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Fibersol-2 resistant Maltodextrin: Functional Dietary Fiber Ingredient

Table 5.1 Improvement of Stool Conditions by Resistant Maltodextrin
Stool Wet Weight (g) Test Group (n = 8) Control (n = 8) 778.2 93.2* 571.5 58.7 Stool Dry Weight (g) 180.5 12.9* 137.9 5.6 Moisture (%) 76.8 1.8 76.2 1.7 Defecation Frequencies (n) 5.92 0.40a 4.76 0.36

65

Note: Test group was administered a resistant maltodextrin product (dietary fiber content: 20 g per day). A crossover study. Eight healthy male subjects were administrated controlled meals through the 5-day study period with or without the resistant maltodextrin. Whole stools were collected between the first defecation of a red color indicator taken on the 1st day and the next defecation of the indicator taken on the 5th (last) day. a Significantly different at p <0.05. Source: Satouchi, M. et al., Effects of indigestible dextrine on bowel movements, Japanese J. Nutrition. 51, 31-37, 1993.

Beneficial Effects on Bowel Movement The effect of the resistant maltodextrin on bowel regularity was confirmed in a crossover ingestion study with eight male subjects [2]. During the fiveday study, the subjects were administrated standard meals with a resistant maltodextrin product (dietary fiber content: 20 grams per day) (FS-2 group) and their fecal weight and fecal frequencies were compared with the data obtained by consuming the same controlled meals without resistant maltodextrin (the control group). The FS-2 group had significantly more bowel movements compared to the control group (Table 5.1). The average total fecal weight for the period was significantly higher in the FS-2 group, 778.2 93.2 g compared with 571.5 58.7 g for the control group (p < 0.05); fecal moisture content was not changed in either group. From these results, it was confirmed that resistant maltodextrin is effective to improve bowel regularity, which is one of the important physiological properties consistent with dietary fiber. As suggested from the fecal moisture content, resistant maltodextrin did not cause diarrhea. Improvement in Intestinal Environments Prebiotic Effect: Improvement of Intestinal Microflora The in vitro fermentability of Fibersol-2 was evaluated with stock strains of human intestinal bacteria (Table 5.2) [3]. It was well fermented by major strains of Bifidobacterium and Bacteroides. The degree of fermentation by Bacteroide organisms was comparable or slightly inferior to that of glucose. In an in vivo test with six healthy male subjects who ingested 10 grams of the resistant maltodextrin with every meal for four weeks, the changes in the

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Table 5.2

Fiber Ingredients: Food Applications and Health Benefits

Fermentability of the Resistant Maltodextrin by Various Intestinal Bacteria

Strains Bacteroides B. vulgatus ATCC 848 B. thetaiotaomicron ATCC 12552 B. fragilis NCTC 9343 B. ovatus VPI 10649 B. distasonis VPI 4243 Eubacterium E. aerofaciens VPI 1003 E. biforme VPI 9218 Peptostreptococcus P. productus YIT 0192 Clostridium C. perfringens PB 6 K C. paraputrificum ATCC 25870 C. bifermentans NCTC 506 Staphlococcus S. aureus 209 P Enterobacteriaceae E. coli H-1 K. pneumoniae H-2 E. cloacae H-3 Streptococcus S. thermophilus YIT 2001 S. faecium YIT 2004 Lactobacillus L. gasseri YIT 0192 L. acidophilus YIT 0070 L. salivarius YIT 0089 L. fermentum YTT 0081 L. bulgaricus YTT 0098 L. helveticus YTT 0100 L. plantarum YTT 0101 L. casei YTT 9018 Bifidobacterium B. bifidum 4007 B. bifidum E 319 B. infantis S-12 B. breve YIT 4010 B. breve S-1 B. breve As-50 B. longum 194 b B. longum H-1 B. adolescentis 194 a B. adolescentis YJ-9 Fusobacterium F. varium ATCC 8501 Propionibacterium P. acnes ATCC 6919 Fermentability + + ++ ++ ++ ++

Note: Acid production: +++, within 1 day; ++, 2 days; +, 3 days. ~ : negative. Source: Adapted from Ohkuma, K. et al., Pyrolysis of Starch and Its Digestibility by Enzymes, Denpun Kagaku, 37, 104114, 1990.

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Fibersol-2 resistant Maltodextrin: Functional Dietary Fiber Ingredient

Table 5.3

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Changes in the Ratios of Bifidobacterium and Bacteroides in Total Colon Bacteria (%) among Six Healthy Male Subjects Consuming 30 g of the Resistant Maltodextrin per Day (10 g per meal) for Four Weeks.
Bacteria Bacteroides Bifidobacterium Others
a

Baseline 49.4 6.0 10.5 3.4 40.1 4.2

After 4 weeks 43.2 2.5 17.9 2.7 38.9 2.5

After 8 weeksa 49.8 3.9 13.7 1.9 36.5 2.9

Second measurement made four weeks after consumption of resistant maltodextrin was stopped.

intestinal microflora counts (log number of colony-forming unit per gram of feces) were examined, and the ratios of Bacteroides and Bifidobacterium in percentages are reported in Table 5.3. Although the number of subjects in this study was rather small, a significant change in the intestinal microflora was observed after one month of consuming the resistant maltodextrin on a daily basis. While the population of Bifidobacterium organisms increased, the level of Bacteroides organisms and other non-specified organisms decreased. Production of Short-Chain Fatty Acids Saccharides that are resistant to digestion and reach the large intestine are fermented by intestinal bacteria, producing short-chain fatty acids (SCFA) and gases. The SCFA are considered to have the following properties in the large intestine: anti-inflammatory; a specific energy source for intestinal mucosal cell to promote cell growth, primarily butyric acid; aiding in water movement across the large intestine; and interfering with bile acid reabsorption thus lowering blood cholesterol levels. An in vitro experiment using human feces to ferment resistant maltodextrin was used to illustrate the potential changes in SCFA and pH values in the colon (Figure 5.4) [4]. Three sources of dietary fiber were incubated under anaerobic conditions with fecal samples taken just after defecation. The formation of SCFA and changes in pH were observed over a 24-hour period. Fructooligosaccharide is known to be completely fermented. The fermentation of resistant maltodextrin and FOS, as measured by the production of SCFA, was similar over the first 1.5 hours. After 6 hours, the fermentation of FOS was basically complete, but the fermentation of resistant maltodextrin was only 56% of that observed for FOS. While it took the complete 24 hours to ferment the gum arabic to achieve SCFA levels equivalent to that observed with FOS, the amount of SCFA resulting from the fermentation of resistant maltodextrin was only approximately 75%. This lower level of SCFA production of resistant maltodextrin compared to the fermentation of equal amounts of FOS and gum arabic attribute to the fact that not all resistant maltodextrin is fermented in the large intestine after ingestion (Figure 5.4). This in vitro experiment helps support the concept that resistant maltodex-

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Fiber Ingredients: Food Applications and Health Benefits

7.0 6.5 6.0 5.5

Time (hr) 1.5 6 11 24

Total SCFA (mmol/g) FOS MD GA 1.08 1.02 0.06 7.12 3.20 0.30 7.26 4.08 1.42 7.66 6.01 8.08

FOS RMD GA

FOS: Fructo Oligo Saccharide MD: Fibersol-2 GA: Gum Arabic SCFA Production

pH

12 Time (hr)

18

24

pH Value Changes

FIGuRe 5.4 Total short-chain fatty acids accumulation and changes in pH values by in vitro fermentation with human feces. 1 ml of diluted human feces (1:10 wt/v) was incubated with 75 mg of each substrate in 9 ml of buffer. FOS (): fructooligosaccharides, MD (): resistant maltodextrin, GA (): gum arabic. (Adapted from Flickinger, E. A., Wolf, B. W., Garleb, K. A., Chow, J., Leyer, G., J., John, P. W., and Fahey, G. C., J. Nutr. 130, 12671273, 2000.)

trin is both effective in aiding laxation and serves as an energy source for intestinal bacteria, a prebiotic. The rapid fermentation of resistant maltodextrin observed at the start of the incubation indicates that the low-molecularweight fraction of resistant maltodextrin can be easily utilized by a variety of bacteria in the large intestine. Maintenance of Digestive Tract Functions When a non-residual, completely digested and absorbed enteral feeding system is administrated for a long period of time, the patient can suffer from gastrointestinal malfunctions such as diarrhea, constipation, or abdominal distention, all caused by lack of dietary fiber. During these extended periods of non-residual enteral nutrition, the intestine will lose its normal physiological functions and significantly reduce its absorptive surface area, mainly the reduction in size of the intestinal villi. The intestine will begin to atrophy. The favorable effect of the resistant maltodextrin when added to a non-residual enteral formula was evaluated in a two-week feeding study in rats. An enteral nutrition formula was fortified with or without 1.4% Fibersol-2, while stock diet was fed to a third group of rats as the control. Distinct morphological changes were observed in jejunal mucosal microvilli with the microscope. More regularly spaced and orientated microvilli were observed in the jejunal sections of rats intestines fed the stock diet and enteral formula with resistant maltodextrin compared to that fed the non-residual enteral formula without resistant maltodextrin (Figure 5.5). Although not evaluated in this study, the production of SCFA through the fermentation of fermentable carbohydrates is considered to help maintain the structure and physiological functions of small intestinal mucosa [5]. These are examples of

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Control (Stock Diet)

Enteral Formula (no ber)

Enteral Formula with 1.4% Fibersol -2

FIGuRe 5.5 Micrograph of jejunal mucosal microvilli of rats fed on each diet for two weeks. (From Ohkuma, K., and Wakabayashi, S., Fibersol-2: a soluble, non-digestible, starch-derived dietary fibre, Advanced Dietary Fibre Technology, McCleary, B.V., and Prosky, L., Eds., Blackwell Science, Oxford, UK, 509523, 2001.)

events occurring in the intestine that help maintain it by impacting primary and secondary nutritional aspects. attenuation of Postprandial blood Glucose levels In a rat study in which these animals were fed digestible disaccharides and larger (DP2), the addition of Fibersol-2 to their diet suppressed the postprandial rise in blood glucose and insulin levels. However, the resistant maltodextrin was not effective to attenuate postprandial blood glucose and insulin levels when rats were fed glucose or fructose, such as monosaccharides [6]. The effects of feeding a single meal with Fibersol-2 are reported by Tokunaga and Matsuoka as illustrated in Figure 5.6 [7]. The subjects consumed a meal of wheat noodles and steamed rice with a tea beverage containing 5 g of Fibersol-2 and were monitored for postprandial blood glucose levels. In Figure 5.6a, which shows the average of all subjects, the peak blood glucose levels (at 30 and 60 min) were significantly lower among subjects consuming the resistant maltodextrin compared to subjects not consuming resistant maltodextrin with their meal. The subjects were further classified into two groups based on the magnitude of the postprandial blood glucose responses. One group of subjects having the higher (Figure 5.6b) postprandial peak blood glucose levels than the average was compared to subjects having the lower postprandial peak blood glucose levels than the average (Figure 5.6c). In the group of subjects having high postprandial blood glucose levels, their attenuation in postprandial blood glucose levels was significantly (p<0.01) more pronounced and therefore more beneficial with consumption of resistant maltodextrin (Figure 5.6b), compared to the attenuation observed in the subjects with lower postprandial blood glucose levels (Figure 5.6c). Consumption of 5 grams of resistant maltodextrin alone to fasting individuals caused no change in their postprandial blood glucose levels (Figure 5.6d),

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250 Blood Glucose Levels (mg/dl) 200 150 100 50

Fiber Ingredients: Food Applications and Health Benefits

Time (hour) FIGuRe 5.6 Effects of tea beverage containing the resistant maltodextrin on postprandial blood glucose (BG) levels when loaded a standard-meal (mean value). : standard meal + 340 g green tea (control), : standard meal + test drink (340 g tea beverage containing Fibersol-2). a: Mean BG curve of 40 subjects, b: Mean BG curve of 18 in 40 subjects whose peak BG levels were higher than the mean value (172 mg/dl) with standard meal + green tea loading, c: Mean BG curve of 22 in 40 subjects whose peak BG levels were <172 mg/dl, d: Mean BG curve of 6 subjects with 340 g test drink alone loading. *: p<0.05, **: p<0.01. (Tokunaga, K., and Matsuoka, J. Japan Diabetes Society, 42, 6165, 1999.)

indicating that the resistant maltodextrin has no contribution to hypoglycemia or hyperglycemia. The attenuation of postprandial blood glucose achieved with the consumption of resistant maltodextrin has been verified in other meal-loading experiments [811]; as part of the evidential studies for approving the Japanese Foods for Specified Health Use (FOSHU) products, more than 30 clinical studies have been reported on the meal-loading effect of Fibersol-2 on blood glucose attenuations. Improvement in Sugar and Fat Metabolism by Repeated Ingestion Decreases in Total Cholesterol and Triglyceride levels Long-term feeding studies in rats and humans fed Fibersol-2 have demonstrated decreases in total cholesterol and triglyceride levels [1214]. In rat studies, these animals were fed diets high in sucrose without cholesterol and their serum lipids were monitored. Total serum cholesterol and triglyceride levels were found to be significantly decreased with the administration of resistant maltodextrin [1314]. Five patients having non-insulin-dependent diabetes mellitus (NIDDM) accompanied with hyperlipidemia were given 20 grams of Fibersol-2 per meal for three months. Changes in blood parameters over the 12-week period among these individuals are reported in Table 5.4. At the start of the experiment, fasting blood glucose levels, total cholesterol levels, and triglyceride levels were above normal ranges. However, after 12 weeks, significant reduc-

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Fibersol-2 resistant Maltodextrin: Functional Dietary Fiber Ingredient

Table 5.4 Effects of Resistant Maltodextrin (20 g per meal) on Serum Lipid and Plasma Glucose Levels, Erythrocyte counts, and Liver Function in NIDDM Patients (n = 5) with Hyperlipidemia.
Time (week) FPG (mg/dl) Cholesterol (mg/dl) HDL-Cholesterol (mg/dl) Triglyceride (mg/dl) Ca (meq/l) Mg (mg/dl) P (mg/dl) Fe (g/dl) RBC (104/mm3) GOT (IU/l) GPT (IU/l) -GTP (IU/l) LDH (IU/l) 0 147 17 265 10 49 2 243 34 4.5 0.3 2.0 0.2 3.0 0.2 96 43 488 31 22 10 22 5 69 38 293 36 2 112 25 211 29 45 1 163 33 4.3 0.3 2.0 0.2 3.3 0.4 98 29 4 107 7 209 22a 47 3 134 24a 4.5 0.2 2.0 0.2 3.3 0.5 99 18 8 147 21 205 10b 49 3 148 11a 4.5 0.2 2.0 0.2 3.2 0.4 97 16 12

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103 7a 209 9b 40 3b 176 42 4.5 0.2 2.0 0.1 3.4 0.3 88 14 488 14 19 4 19 4 63 54 311 95

Note: FPG: fasting plasma glucose, RBC: Erythrocyte count. MeanSD, statistical significance: a p<0.05, b p<0.01 compared with data at 0 week. Source: Nomura, M., Nakajima, Y., and Abe, H., J. Jpn. Soc. Nutr. Food Sci., 45, 21-25, 1992.

tions in blood glucose and cholesterol levels were observed (Table 5.4). Blood triglyceride levels decreased by 28%, but this decrease was not significant [15]. In another placebo-controlled double-blind study, subjects were given a tea beverage with 5 grams of the resistant maltodextrin or a placebo (without resistant maltodextrin) three times a day for four weeks. Triglyceride levels were significantly reduced (p<0.05) after consumption of the tea containing resistant maltodextrin (Figure 5.7) [16]. Triglyceride levels generally returned to starting levels after subjects stopped consuming the resistant maltodextrin. It can be assumed that the long-term regulation or attenuation in postprandial blood glucose and insulin levels by consuming the resistant maltodextrin with every meal affects these chronic triglyceride and total cholesterol levels. Decreases in body Fat Ratio It has been reported that the intake of a tea beverage containing 5 grams resistant maltodextrin with every meal for four weeks significantly lowered body weight, BMI, body fat ratio, and waist/hip ratio [16]. Similar results were observed in a study among 12 adult male subjects. They consumed 10 grams of resistant maltodextrin per meal for three months. At the start and upon termination of the three-month test period, glucose tolerance tests

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60 40 Triglyceride (mg/dl) 20 0 20 40 60 80

Fiber Ingredients: Food Applications and Health Benefits

Test group Placebo group

** Administration Period Before Before Pre-administration Administration

*p < 0.026 (t-test) **p < 0.003 (paired t-test)

After After Administration Post-administration

FIGuRe 5.7 Changes in serum triglyceride levels by four-week ingestion of the resistant maltodextrin. : test group, 250 ml of tea beverage containing 5 g Fibersol-2, : placebo group, 250 ml of placebo tea beverage. Three times (every meal) per day ingestion for four weeks. MeanSEM. (From Kajimoto, O. et al., J. Nutritional Food, 3 (3), 4758, 2000.)

were assessed and blood chemical parameters were measured. Body fat was also measured by impedance, and the area for visceral fat and subcutaneous fat were measured by computed tomography (CT) scans [17]. Results of this experiment are reported in Figure 5.8. Glucose tolerance, body fat ratios, and visceral fat areas were significantly decreased by the ingestion of the resistant maltodextrin. Two indices of insulin resistance, total immunoreactive insulin ( IRI) and homeostasis model assessment insulin resistance index (HOMA-IR), were also decreased after consumption of resistant maltodextrin. It is assumed that resistant maltodextrin prevents the accumulation of fat (obesity) by moderating the postprandial rise in blood glucose and insulin levels, which would be a similar, but still unexplained mechanism(s) to decrease serum total cholesterol and triglyceride levels.

Safety and Food Applications

Safety Fibersol-2 has been approved as a Generally Recognized As Safe (GRAS) material, manufactured by enzymatic hydrolysis of pyrodextrin. Its safety was reviewed and authorized by the FDA in 1990 and it is classified as a

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Physiological Examination Before Intake (start) 3-Month Intake Age (years old) 46.1 3.0 Height (cm) 168.8 1.3 73.0 3.3 Body Weight (kg) 73.7 3.4 25.6 0.9 BMI 25.8 0.9 25.9 1.0* 27.7 0.9 Body Fat (%) 89.5 2.3 90.8 2.4 Waist (cm) 98.3 2.1 98.8 2.1 Hip (cm) 0.91 0.01 0.91 0.01 W/H 101.9 11 .6 108.0 13.7 V: Area for Visceral Fat (cm2) 163.9 19.9 175.2 25.2 S: Area for Subcutaneous Fat (cm2) 0.64 0.07 0.70 0.1 V/S n = 12, average SEM n = 9, only for V, S, V/S values *: Pair-matching t-test, signicantly dierent from initial values at p < 0.05.

Glucose Tolerance 250 Blood Glucose (mg/dl) 200 150 100 50 0 30 60 Time (min) Start 3-month administration Start 90 120 Blood glucose levels 100 Insulin (U/ml) 75 50 25 0 30 60 Time (min) 3-month administration 90 120 Insulin levels

n = 10, average SEM *: Pair-matching t-test, signicantly dierent from initial values at p < 0.05. **: Signicantly dierent from initial values at p < 0.01. FIGuRe 5.8 Changes in physical examination and glucose tolerance by three-month ingestion of the resistant maltodextrin. 10 grams, 3 times (every meal) per day (= 30 grams) of resistant maltodextrin was administrated for 3 months. Graphs of glucose tolerance test. Left: blood glucose levels, right: insulin levels. : glucose or insulin response at the start time, : glucose or insulin response after three-month administration of resistant maltodextrin. (From Kishimoto, Y., Wakabayashi, S., and Tokunaga, K., J. Jpn. Assoc. Dietary Fiber Res., 4 (2), 5965, 2000.)

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Fiber Ingredients: Food Applications and Health Benefits

maltodextrin (21 CFR 184.1444). Safety studies have been accomplished on the potential consumption of high levels of the resistant maltodextrin. The lethal dose (LD50) determined in a rat feeding experiment was over 40 g/kg body weight, the maximum dosage in the acute toxicity study. There is no evidence of any mutagenicity caused by the consumption of the resistant maltodextrin [18]. Dietary fiber has been reported to inhibit the absorption of essential microelements. However, resistant maltodextrin was found to have no binding capacity for mineral ions when evaluated in an in vitro experiment [19]. A study in which rats were fed water containing 10% resistant maltodextrin for five weeks, showed no harmful effects on internal organs such as the pancreas, kidneys, and liver, including functional indices [13]. The effects of large intakes of resistant maltodextrin on gastrointestinal responses and fecal parameters were evaluated in a study that used 74 healthy adult subjects. Subjects were given a single dose of the resistant maltodextrin ranging from 10 to 60 grams. This particular resistant maltodextrin product contained 58% dietary fiber. Feeding these varied amounts of resistant maltodextrin to these subjects did not cause any clinical or problematic gastrointestinal symptoms. The ED50 (effective dose 50, the amount of material required to produce a specified effect in 50% of an animal population) to cause diarrhea was estimated to be more than 110 grams of a product containing 58% total dietary fiber (63 grams for a 100% dietary fiber product) [20]. Resistant maltodextrin would have less tendency to cause diarrhea compared to sugar alcohols or other totally fermentable oligosaccharides because it has a higher molecular weight than these materials, and approximately 40% is passed to the feces after consumption. Food applications Resistant maltodextrin is a very user-friendly dietary fiber because of its low viscosity and its tasteless and flavorless characteristics, in addition to high stability in heat and acid; it can be added easily into any type of foods in the same manner as sugar or salt. Before such user-friendly dietary fiber was developed, the fiber sources used to fortify processed food products would have been cereals, vegetable, fruits, etc. In place of such ingredients, resistant maltodextrin can be added to any processed foods as a source of dietary fiber to enable the producers to make dietary fiber fortification claims such as Rich in fiber or Good source of dietary fiber without compromising quality characteristics of the fortified products. The Japanese Ministry of Health, Labor and Welfare has an approval program called Tokuho, Food for Specified Health Use (FOSHU), in which the approved products are allowed authorized claims, such as Improves intestinal regularity or Beneficial for those concerned about blood glucose

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levels. Numerous FOSHU products with Fibersol-2 as the effective key ingredient have been introduced into the marketplace. Resistant maltodextrin is also used in low-calorie foods. When added with high-intensive sweeteners such as aspartame, sucralose, stevia, or acesulfame K, resistant maltodextrin provides significant body and texture to achieve a highly desirable sweetness with no harsh aftertaste. The caloric value for Fibersol-2 is considered ~1.0 kcal/g [1, 21, 22].

Measuring Method of Total Dietary Fiber in Foods Containing Resistant Maltodextrin

Although resistant maltodextrin functions fully as dietary fiber, it is necessary to determine its actual dietary fiber content for the purpose of nutrition labeling. The total dietary fiber value of resistant maltodextrin is not accurately determined by AOAC Official Method 985.29, in which the soluble dietary fiber components are precipitated in 78% ethanol. Therefore, an analytical method was developed to accurately measure the total dietary fiber content in foods containing resistant maltodextrin (Figure 5.9). This method has been approved through AOAC collaborative study, and has received Final Action approval as AOAC Official Method 2001.03 [23]. This method is applicable for nutrition labeling. As the first step, insoluble and high-molecular-weight soluble dietary fiber components are measured by AOAC Official Method 985.29. The material is treated with enzymes, four volumes of ethanol, and the residue and the filtrate are separated. The salts and protein remaining in the filtrate after the AOAC Official Method 985.29 protocol employed are removed by ion-exchange resins. The deionized filtrate is analyzed by high-performance liquid chromatography analysis to determine the low-molecular-weight soluble dietary fiber that does not precipitate in 78% ethanol. The amount of total dietary fiber is calculated by summing the insoluble and high-molecular-weight soluble dietary fiber with the low-molecular-weight soluble dietary fiber.

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(Enzymatic-Gravimetric Method) 1.0 g Sample 0.08 M Phosphate buer, pH 6.0 -amylase 95C, 30 min pH 7.5 0.1

Protease 60C, 30 min pH 4.5 0.2

Amyloglucosidase 60C, 30 min 4 vol. 95% EtOH Filtration Washing

78% EtOH3 95%EtOH2 Aceton2

(LC determination) Filtrate Evaporation

Residue Ash and Protein Correction IDF + HMWSDF

Washing out the concentrate inside the ask by using deionized water and pipetts several times Glycerol solution Desalting Evaporation Adjusting vol. HPLC LMW RMD

FIGuRe 5.9 Flow diagram for analytical procedure of the AOAC Official Method 2001.03, dietary fiber in foods containing resistant maltodextrin, high MW RMD by 985.29 (IDF and SDF) and low MW RMD by liquid chromatography. (From Official Methods of Analysis, 18th ed., AOAC International, 2006.)

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References
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16. Kajimoto, O. et al., Beneficial effects of a new indigestible dextrin-containing beverage on lipid metabolism and obesity-related parameters, J. Nutritional Food, 3(3), 47-58, 2000 (in Japanese). 17. Kishimoto, Y., Wakabayashi, S., and Tokunaga, K., Effects of long-term administration of indigestible dextrin on visceral fat accumulation, J. Jpn. Assoc. Dietary Fiber Res., 4(2), 5965, 2000 (in Japanese). 18. Wakabayashi, S. et al., Acute toxicity and mutagenicity studies of indigestible dextrin, and its effect on bowel movement of the rat, J. Food Hyg. Soc. Japan, 33, 557562, 1992 (in Japanese). 19. Nomura, M. et al., Effect of dietary fibers on the diffusion of glucose and metal ions through cellulose membrane, J. Jpn. Soc. Clin. Nutr., 13, 141147, 1992 (in Japanese). 20. Satouchi, M. et al., Effects of indigestible dextrine on bowel movements, Jpn. J. Nutr., 51, 3137, 1993 (in Japanese). 21. Goda, T. et al., Availability, fermentability, and energy value of resistant maltodextrin: Modeling of short-term indirect calorimetric measurements in healthy adults, Am. J. Clin. Nutr., 83, 13211330, 2006. 22. Nakamura, S. and Oku, T., Evaluation of available energy of several dietary fiber materials based on the fermentability from breath hydrogen excretion in healthy human subjects. J. Jpn. Assoc. Dietary Fiber Res., 9, 1, 3445, 2005. 23. Okuma, K. and Gordon, D. T., Determination of total dietary fiber in selected foods containing resistant maltodextrin by enzymatic-gravimetric method and liquid chromatography: Collaborative study, J. AOAC Int., 85, 435444, 2002.

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