Original Article

診療と新薬 2019; 56: 358‑364

Attenuating Eﬀect of Isomaltodextrin Contained in Breadon Postprandial Plasma Glucose Levels in Healthy Humans:

診療と新薬 WebA Randomized, Placebo-controlled, Double-blind Crossover Study

Takeo SAKURAI 1）／Yuki ISHIDA1）／Shin-ichiro INOUE 1）／Mayumi KUROSE 1）／
Yukinobu UCHIDA1）／Nariaki YOSHIDA1）／Tsuyoshi SADAKIYO 1）／Hikaru WATANABE 1）／
Hitoshi MITSUZUMI 1）／Shimpei USHIO 1）／Junichi HIRAMATSU 2）● Abstract
Objective: The purpose of this study was to examine whether isomaltodextrin (IMD) attenuates elevatedblood glucose levels following meal intake.
Methods: Overnight-fasted subjects (n = 30) consumed bread (containing IMD or not containing IMD) withbreakfast, and blood glucose levels were determined over time from immediately before to 120 minutes after
meal intake. The study was conducted with or without intake of 2.93 g of IMD in a double-blind crossoverstudy.
Results: No diﬀerences were observed in blood glucose levels over time after the meal between IMD intake
and non-IMD intake in all subjects. However, a stratiﬁed analysis of subjects with a tendency for increased
postprandial blood glucose levels showed a signiﬁcant higher attenuating eﬀect of IMD intake on blood glucose
elevation compared with non-IMD intake in terms of blood glucose levels over time and area under the curve.
Conclusion: Results of this study suggest that IMD attenuates elevated blood glucose levels following mealintake.
Key Words: Isomaltodextrin, Soluble dietary ﬁber, Postprandial blood glucose level, Bread

1. INTRODUCTION
Excessively high blood glucose levels following a meal isa risk factor for type 2 diabetes mellitus1). In 2013, thenumber of patients with diabetes aged 20‒79 years wasestimated at approximately 7.2 million in Japan andapproximately 380 million worldwide, according to areport by the International Diabetes Federation2). In mostdeveloped countries, uncontrolled diabetes is associatedwith complications such as diabetic neuropathy, renal
failure, blindness, large vessel disease, and death 1).
Therefore, it is extremely important to control excessivechanges in blood glucose levels following food intake.
Isomaltodextrin (IMD) is a new highly branched
α-glucan produced enzymatically from starch using
α-glucosyltransferase and α-amylase derived from
Paenibacillus alginolyticus PP7103). IMD is composed onlyof glucose units, and exhibits approximately 17%
α-1,1-glucosidic linkages (non-reducing end), 3%

1) R&D Division, Hayashibara Co., Ltd.
2) Hiramatsu Clinic
TEL: +81-86-276-3141 FAX: +81-86-276-8670
E-MAIL address: takeo.sakurai@hb.nagase.co.jp

α-1,3-glucosidic linkages, 19% α-1,4-glucosidic
linkages, 49% α-1,6-glucosidic linkages, 7%
α-1,3,6-glucosidic linkages, and 5% α-1,4,6-glucosidic
linkages. IMD has a weight-average molecular weight ofapproximately 5,000 (Figure 1). IMD is highly soluble inwater and hardly aﬀects the taste or ﬂavor of the food towhich it is added. The dietary fiber content of IMD
determined using an enzyme-HPLC method (AOAC
2001.03) was 侒 80% on the solid basis 4). Indigestible
dextrin and polydextrose are also soluble dietary fibers
comprised of glucose. Compared with these substances,
IMD exhibits a unique structure, consisting of only
α- g l u c o s i d i c l i n k a g e s a n d e x h i b i t i n g m o r e
α-1,6-glucosidic linkages. Therefore, IMD is expected tohave physiological effects distinct from those ofindigestible dextrin and polydextrose.
It has been reported that IMD attenuates elevated blood
glucose levels after carbohydrate loading5)6). However,
the eﬀects of IMD on elevated postprandial glucose levels
have not yet been reported. Thus, we examined whether
IMD contained in bread attenuates elevated blood glucose
levels.

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第 5 号（2019 年 5 月）

7 （359）（a）Nonreducing end α-Glcp（b）1,3-linked α-Glcp（c）1,4-linked α-Glcp（d）1,6-linked α-Glcp（e）1,3,6-linked α-Glcp（f）1,4,6-linked α-Glcp（g）reducing-end Glcp

Figure 1. The putative structure of IMD.

2．MATERIALS AND METHODS
2.1. Subjects
Subjects were healthy adult (19 male, 11 female)
employees of Hayashibara Co., Ltd., who gave consent toparticipate in the study and met the inclusion criteria.
The major inclusion criteria were: no medical history or
medication that may have eﬀects on the study. Subjects
who met the above requirements and were consideredhealthy and eligible by the investigator were registeredto participate in the study.
Exclusion criteria were in place to enable the selectionof healthy subjects likely to show a blood glucose increase
within a certain range, while also considering theirsafety. The following subjects who were suspected tohave hypoglycemia (at fasting), postprandial
hyperglycemia (120 minutes after intake) or
hyperglycemia (at fasting or at random) at eachmeasurement time point were excluded from theanalysis: (a) fasting blood glucose levels < 60 mg/dL or侒 126 mg/dL7)8), (b) blood glucose levels 侒 189 mg/dL at
120 minutes after meal9), or (c) random blood glucose
levels 侒 270 mg/dL8). The guidelines used for the above
criteria were based on glucose levels in the venous blood.
Fasting blood glucose levels were nearly the same
between the ﬁnger-stick blood collection (capillary blood)
performed for this study and routine blood collection(venous blood collected from the elbow); however, ablood glucose level after carbohydrate loading wasreported to be up to 1.35-fold higher in the capillary bloodthan in the venous blood10). Therefore, each criterion
after carbohydrate loading was multiplied by 1.35 andused as a conversion value.
2.2. Test substance
IMD (Hayashibara Co., Ltd., Okayama, Japan) was usedas the test substance. The dietary ﬁber content of IMD
determined using the enzyme-HPLC method (AOAC
2001.03) was 86.1% on the dry solid basis (Table 1a).
Two types of koppepan (similar to a hot dog bun; Bread A
not-containing IMD and Bread B containing IMD) wereprepared according to a general recipe. Bread B
containing IMD contained 2.93 g of IMD on a solid basis.
Both Bread A and B weighed about 70 g after baking.
The amount of added dietary fiber was not decreased
after baking, as confirmed by enzyme-HPLC. The
subjects did not seem to be able to distinguish between
the test and control meals because IMD is mostly
tasteless, colorless, and odorless.
Overnight-fasted subjects consumed breakfast including
Bread A or B with jam (AOHATA 55 Portion JamStrawberry [13 g per cup], AOHATA Corporation,
Hiroshima, Japan) and tea beverage (Afternoon Delicious
Tea without sugar, Kirin Beverage Company, Limited,Tokyo, Japan) (Tables 1a and 1b). The breakfast
contained 2 pieces of Bread A, 2 cups of jam, and 200 mLof tea beverage for a meal without IMD; and 1 piece ofBread A, 1 piece of Bread B, 2 cups of jam, and 200 mLof tea beverage for a meal with IMD (the meal without
IMD contained 80.2 g of carbohydrate and 450.4 kcal of
total energy)11).
2.3. Study design
To unify the study conditions as much as possible acrossthe two intake tests, a pre-speciﬁed meal was served forsupper on the day before the test and any intake of foods
other than the pre-speciﬁed meal was prohibited after 6

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第 5 号（2019 年 5 月）

Table 1a. Koppepan used for testing

Bread A
（not containing IMD）
Bread B
（containing IMD）

Content of IMD

Weight before baking

-

77 g

2.93 g80 g（including the weight of IMD）

Table 1b. Test meal
Product name

Ingredients

Nutrition facts
Calories
Total Carbohydrate
Protein
Total Fat
SodiumKoppepan

Strawberry jam

Tea beverage

Flour, baker s yeast, bread quality improving Strawberry, sugars (sucrose, glucose Black tea
agent, sugar, salt, fat-free milk powder, egg, ［liquid］, fructose)/gelling agent（Darjeeling Tea
and margarine（random order）（pectin）, and acidiﬁer73％）/ﬂavor,（when preparing bread containing IMD,and vitamin C
IMD was added to the above ingredients）（2 pieces［bread not-containing IMD］）
408.4 kcal
69.8 g10.4 g8.2 g
1.4 g

p.m. on the day before the test in this study. Drinks werealso limited to water or barley tea after 6 p.m. in a similarmanner. The subjects consumed the pre-specified meal
for supper between 6 p.m. and 9 p.m. on the day before
the test, and they were not allowed to eat or drink fromafter supper until the end of the test on the following day.
To prevent dehydration, however, subjects were allowed
to drink an appropriate amount of water or barley tea
prior to the start of the test.
On the day of the test, subjects who were conﬁrmed to
be in good health based on the results of both aquestionnaire on health eligibility and fasting blood
glucose measurements, consumed breakfast (with orwithout IMD) over the course of 15 minutes. Thereafter,
the subjects were kept at rest in a sitting position to theextent possible for about 2 hours until the end of the test.
To minimize variability in blood glucose levels, subjects
were not allowed to eat or drink anything other than the
pre-specified meal during the test. Blood glucose levels
were determined by the subjects immediately before (atfasting) and 30, 45, 60, 90, and 120 minutes after mealintake (6 times in total). Test strips (Accu-Chek Aviva
Test Strip F, Roche Diagnostics, Basel, Switzerland) of
the same lot were used for determination of blood glucose
levels. The series of tests were performed for the 2 typesof breakfast separately. A washout period of at least one
week was allowed between tests.
A total of 30 subjects were divided into two groups byblock randomization, and were assigned to one of two
intake order groups (without IMD → with IMD, or with
IMD → without IMD) in a double-blind crossover fashion.

（2 cups［13 g per cup］）
42 kcal10.4 g0g
0g
4 mg［200 mL］
0 kcal
0g
0g
0g
12 mg

The assignment list was sealed and strictly kept until theend of the study. Test meals were prepared and labeledby the same person that assigned the subjects to thestudy groups.
2.4. Evaluation items
Evaluation items included the time course of blood
glucose levels from 0 to 120 minutes, change in blood
glucose levels from baseline (Δ blood glucose level), area
under the blood glucose level-time curve (AUC), and area
under the Δ blood glucose level-time curve (Δ AUC).
Comparisons were made for maximum blood glucose
levels (Cmax) and maximum levels of Δ blood glucose (ΔCmax) between meals with and without IMD.
In addition to an analysis of all subjects, a stratified
analysis was also performed for subjects with a tendency
for increased postprandial blood glucose levels. A subject
with a tendency for increased postprandial blood glucose
levels was deﬁned as a subject whose ΔCmax was 侒 70 mg/
dL after intake of a meal without IMD, based on aprevious report5).
2.5. Measurement of the density of aqueous solutionsof IMD
The densities of aqueous solutions of IMD andmaltodextrin (Pinedex #1, Matsutani Chemical Industry
Co., Ltd., Hyogo, Japan), with nearly the same dextrose
equivalent (DE) as IMD, were measured. Six different
IMD aqueous solutions (10% to 60%［w/w］) and 4
diﬀerent maltodextrin aqueous solutions (10% to 40%［w/w］) were prepared, and their concentrations wereprecisely determined using a heat drying under reducedpressure method (siliceous earth method). The specific診療と新薬・第 56 巻

gravity of each sample solution was measured at 20℃ and
40℃ using a pycnometer. The density of each sample wascalculated by multiplying the specific gravity with thedensity of water (0.9982 g/cm3 at 20℃ and 0.99222 g/cm3
at 40℃). The density of each concentration was
calculated by linear regression.
2.6. Ethics
This study was approved by the institutional review
board for volunteer studies at Hayashibara Co., Ltd.
(approved on December 4, 2017 [Registration No. 210]),and thereafter conducted in accordance with the
Declaration of Helsinki and Ethical Guidelines for Medicaland Health Research Involving Human Subjects under
supervision of physicians with an adequate support
system. All subjects received complete information on
the importance, purpose, and protocol of the study, andsigned a consent form regarding participation in the study
and publication of the study results.
2.7. Statistical analysis
All values are expressed as mean ± standard deviation(SD). AUC was calculated using the trapezoid formula.

第 5 号（2019 年 5 月）

9 （361）

Statistical analysis of data was performed using the
Wilcoxon signed-rank test with a p value 侑 0.05 (twosided) being considered statistically signiﬁcant. Statcel2,
an add-in for Microsoft Excel, was used for statisticalanalyses.

3．RESULTS
3.1. Subjects
Before the study was completed, 2 subjects dropped outof the study due to poor health conditions, resulting in a

Table 2. Characteristics of all subjects（n ＝ 28）
41.1 ± 8.6
167.9 ± 6.5
64.3 ± 11.1
22.8 ± 3.3
24.4 ± 5.9

Age
Body height
Body weight
BMI
Body fat percentage

years
cm
kg
kg/m2

（mean ± standard deviation）

A. Blood glucose levels

Cmax（mg/dL）

Blood glucose level（mg/dL）

200

100

175
150
125

50

0

30

60
90
Time（minute）

120

100

A-3 AUC of blood
glucose levels
350
AUC（mg/dL・hr）

A-2 Cmax of blood
glucose levels
200

A-1 blood glucose levels

150

300
250
200
150

IMD− IMD＋

IMD− IMD＋

B. Δ Blood glucose levels

Δ Cmax（mg/dL）

Δ Blood glucose level（mg/dL）

100

50
25
0

0

30

60
90
Time（minute）

120

100
75
50
25

B-3 AUC of Δ blood
glucose levels
125
Δ AUC（mg/dL・hr）

B-2 Cmax of Δ blood
glucose levels
125

B-1 Δ blood glucose levels

75％

IMD− IMD＋

100

75

50

IMD− IMD＋○ or white bar ＝ intake without IMD, ● or black bar ＝ intake with IMD
Mean ± standard deviation（n ＝ 28）
Figure 2. Changes in blood glucose levels over time after breakfast intake（all subjects）

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診療と新薬・第 56 巻

total of 28 subjects (18 male and 10 female) included in
the ﬁnal analysis. The characteristics of all subjects areshown in Table 2.
3.2. Blood glucose levels
Blood glucose results for all subjects are shown in
Figure 2. Postprandial blood glucose levels and Δ blood
glucose levels reached a maximum at 45 minutes after
intake and gradually declined through 120 minutes after
intake, regardless of the addition of IMD. There were nodifferences in blood glucose levels over time between
IMD intake and non-IMD intake.
A stratified analysis was performed to examine theeﬀect of IMD on subjects with a tendency for increased
postprandial blood glucose levels. Per the stratification
criteria, 7 subjects (4 male and 3 female) whose Δ Cmax
was 侒 70 mg/dL after intake without IMD wereconsidered as having a tendency for increased
postprandial blood glucose levels. The characteristics ofsubjects with a tendency for increased postprandial blood
glucose levels are shown in Table 3.

第 5 号（2019 年 5 月）

Results of the stratiﬁed analyses are shown in Figure 3.
Postprandial blood glucose levels and Δ blood glucose
levels reached a maximum at 45 minutes after intake
without IMD, whereas the time to reach the maximum
was delayed to 60 minutes following intake with IMD.
Furthermore, the maximum level with IMD at 60 minutes
was lower than that without IMD at 45 minutes. BothAUC and Δ AUC were significantly lower following
intake with IMD than without IMD (p = 0.02 for AUC

Table 3. Characteristics of subjects with a tendency forincreased postprandial blood glucose levels（n ＝ 7）
years
cm
kg
kg/m2

41.0 ± 10.6
168.8 ± 6.2
65.8 ± 12.4
23.0 ± 3.5
25.6 ± 5.6

Age
Body height
Body weight
BMI
Body fat percentage％（mean ± standard deviation）

A. Blood glucose levels
A-2 Cmax of blood
glucose levels
200

150
*
＝ 0.06100＝ 0.09

175

*

150
125

50

0

30

60
90
Time（minute）

120

100

A-3 AUC of blood
glucose levels
350
AUC（mg/dL・hr）

200

Cmax（mg/dL）

Blood glucose level（mg/dL）

A-1 blood glucose levels

300
250
200
150

IMD− IMD＋*

IMD− IMD＋

B. Δ Blood glucose levels

75
50

*

25
0

*
0

30

Δ Cmax（mg/dL）

Δ Blood glucose level（mg/dL）

100＝ 0.06＝ 0.0960
90Time（minute）

120

100
75

*

50
25

IMD− IMD＋

B-3 AUC of Δ blood
glucose levels
125
Δ AUC（mg/dL・hr）

B-2 Cmax of Δ blood
glucose levels
125

B-1 Δ blood glucose levels

100

*

75

50

IMD− IMD＋○ or white bar ＝ intake without IMD, ● or black bar ＝ intake with IMD
Mean ± standard deviation（n ＝ 7） ＊：Signiﬁcant diﬀerence compared with intake without IMD（p＜0.05）
Figure 3. Changes in blood glucose levels over time after breakfast intake（subjects with a tendency for increased postprandial
blood glucose levels）

診療と新薬・第 56 巻

第 5 号（2019 年 5 月）

11 （363）

Table 4. Density of aqueous solution
Density ρ4t（g/cm3）
Concentration

IMD〔％（w/w）〕
10
20
30
40
50
60

Maltodextrin

20℃

40℃

20℃

40℃

1.03981.0844
1.1323
1.18371.23901.29851.0332
1.07701.12391.17441.22891.28791.03951.0837
1.1313
1.1830-1.03251.0761
1.12301.1735-and p = 0.02 for Δ AUC). For the secondary analysis,
statistical analyses were carried out at each time point.
R e s u l t s s h o w e d t h a t b l o od gl u c o s e l e ve l s w e r esigniﬁcantly lower at 45 minutes (p = 0.02) and trended
lower at 30 and 90 minutes (p = 0.06 and p = 0.09,
respectively) after intake with IMD compared to intake
without IMD. Δ blood glucose levels were signiﬁcantly
lower at 30 and 45 minutes (p = 0.04 and p = 0.02,
respectively), and trended lower at 60 and 90 minutes(p = 0.06 and p = 0.09, respectively). Furthermore, Cmax
and Δ Cmax of individual subjects were also significantly
lower after intake with IMD compared to intake without
IMD (p = 0.03 for Cmax and p = 0.03 for Δ Cmax).
3.3 Density of aqueous solutions of IMD
The densities of aqueous solutions of IMD were measured
to determine the presence or absence of water
absorbability or swellability, which is the known
mechanism of action of common dietary fibers. An
aqueous solution of 10% (w/w) IMD was found to have adensity of < 1.04 g/cm 3 at 40℃, similar to that of
maltodextrin (Table 4).

4．DISCUSSION
The purpose of this study was to examine whether IMD
attenuates elevated blood glucose levels following mealintake. In this study, 1 koppepan (Bread B) contained
2.93 g of IMD. Analysis of all 28 subjects found that IMD
contained in bread did not show an attenuating eﬀect onelevated blood glucose levels. However, a stratified
analysis of 7 subjects with a tendency for increased
postprandial blood glucose levels did show an attenuatingeﬀect of IMD on blood glucose elevation, consistent withprevious studies6). Specifically, a stratified analysis of 7
subjects whose Δ C max was 侒 70 mg/dL without IMD
showed significantly lower AUC and Δ AUC (0 to 120
minutes) after breakfast intake containing IMD compared
to breakfast intake without IMD. Both blood glucose andΔ blood glucose levels were significantly lower ortrended lower from 30 to 90 minutes after breakfast
intake with IMD compared to breakfast intake without
IMD. Furthermore, Cmax and Δ Cmax of individual subjects

were also significantly lower after intake with IMD
compared to intake without IMD. Thus, the results
suggest that IMD attenuates elevated blood glucose
levels following meal intake in subjects with a tendency
for increased postprandial blood glucose levels.
Rapid elevation in blood glucose levels is normallyattenuated by insulin, which is secreted in response toincreases in blood glucose. The 7 subjects that were
included in the stratiﬁed analysis seem to have had weak
functioning in blood glucose regulation. A rapid increasein blood glucose levels is known to increase the risk ofcardiovascular events12). The attenuating eﬀect of IMD on
blood glucose elevation in subjects with a tendency forelevated postprandial blood glucose levels suggests that
introduction of IMD into daily life may help to reduce therisk of cardiovascular events.
It is interesting to note that the attenuating effect of
IMD on elevated blood glucose levels in the stratified
analysis was more remarkable than the effect observed
following glucose solution intake (with 5 g of IMD).
Results of previous studies demonstrated that theattenuating eﬀect of IMD on elevated blood glucose levels
was weaker at 2.5 g of IMD6) compared with 10 g or 5 g5)in a dose-dependent fashion in subjects with a tendency
for increased postprandial blood glucose levels. In
addition to the inhibitory effect of IMD on glucose
absorption from the intestine, IMD was also shown to
inhibit the activity of maltase and isomaltase, which aresmall intestinal mucosal enzymes 5) ; however, theinhibition rate was only 〜10%5) . Therefore, theattenuating eﬀect of IMD on elevated blood glucose levels
seems to be largely attributable to inhibition of glucose
absorption. The dose-dependent attenuating effect of
IMD on elevated blood glucose levels may be due to thefact that the inhibitory effect on glucose absorption
cannot catch up with the amount of supplied glucose that
surpasses the effect of IMD. Accordingly, IMD
administered with a meal, in which glucose is slowly
supplied to the intestine via the digestive process, may
efficiently inhibit glucose absorption compared with a
glucose solution, in which glucose reaches the intestineat once, and could explain the eﬀects noted above.

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Some dietary fibers are known to attenuate elevatedpostprandial blood glucose levels, and are believed toslow glucose absorption by delaying the transit ofingested food into the intestine by either increasing theviscosity of the ingested food or as a result of theirinherent water-absorption/swelling actions, resulting in
attenuation of elevated blood glucose levels13). As IMD
exhibits a low viscosity5), the eﬀect of IMD viscosity on
slowing of glucose absorption is likely to be small. The
density of an aqueous solution of IMD was not remarkably
high at 40℃ (which is close to the temperature of thehuman body), and even at a concentration of 10% (w/w)
there is a high concentration of IMD in feces 14) ,suggesting that swelling or related water-absorption of
IMD is minimal. Therefore, it is likely that IMD inhibits
glucose absorption by a diﬀerent mechanism from that ofother dietary ﬁbers. It is known that glucose is absorbed
from the intestine via a glucose transporter15)16). Futurestudies are necessary to examine the eﬀect of IMD on the
glucose transporter.

5．CONCLUSIONSIn conclusion, IMD attenuates elevated blood glucose
levels following meal intake in subjects with a tendency
for increased postprandial blood glucose levels.
Introduction of IMD into daily life may offer healthbeneﬁts. The attenuating eﬀect of IMD on elevated blood
glucose levels is considered to be the result of inhibitionof glucose absorption via a mechanism of action distinct
from that of dietary fibers, i.e., increasing viscosity or
water-absorption/swelling.
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