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177
Fig. 9.2 Maximum daily average recommended dose of inulin to various population
inulin may affect the absorption of several nutrients and minerals such as iron in
children and adolescents and may induce an imbalance in the nutrient level (Costa
et al. 2020). It can also cause digestive discomfort to some children, especially
when they initiate the consumption of inulin. Children with some health issues such
as inammatory bowel syndrome (IBS) may avoid the inulin intake, as it can worsen
the health condition (Salvatore etal. 2023). Therefore, it is important to monitor the
effect of inulin while initiating the inulin supplementation to the children. Inulin
might be effective in reducing body weight, increasing the fat-free muscle produc-
tion, and reducing obesity in children (Visuthranukul etal. 2022).
Constipation is one the common disorders in young age children, and inulin
supplementation can improve the condition by improving the consistency of stools;
however, some children may face the problem of loose stool after the consumption
of inulin (Closa-Monasterolo etal. 2017). A recent study by Visuthranukul etal. on
9 Toxicity andSafety Aspects ofInulin
178
effect of inulin supplementation to the obese child, found that inulin has the poten-
tial to increase the fat-free mass in these children (Visuthranukul etal. 2022).
9.4.3.2 Adults
Inulin has been reported safe for healthy adults at a high dose range, and even 40g
per day is safe; however, it may vary from person to person and the health condition
of the adults. Unhealthy, overweight, or obese adults or diabetic adults should
decrease the inulin intake and should not consume more than 20–25g per day as
mentioned in Table9.1 (Wijaya etal. 2022; Mitchell etal. 2021; Birkeland etal.
2020; Companys etal. 2022; Chambers etal. 2019).The patient undergoing perito-
neal dialysis also needs to take caution while consuming inulin and should not
increase the intake to more than 10g per day (Xiong etal. 2023).
9.4.3.3 Elderly Individuals
Inulin can induce some side effects in older people, and especially the people with
ulcerative colitis, inammatory bowel disease, or allergies require more caution
while using inulin to avoid any adverse events (Visuthranukul etal. 2022; Cai etal.
2018). Inulin helps to improve the gut microbiota in elderly people, and hence it is
consumed as probiotic, but few of them may experience the hypersensitive reactions
(Teferra 2021).
9.4.3.4 Pregnant or Lactating Women
There is limited research on the safety of inulin supplementation during pregnancy
and breastfeeding. As a precaution, pregnant or breastfeeding individuals should
consult their healthcare provider before using inulin supplements. Women suffering
from overweight or obesity or stress may also require caution in inulin consump-
tion. The gastrointestinal disorders such as atulence, soft stool, and nausea may be
produced at increased intake of inulin-based products (Vaghef-Mehrabani
etal. 2023).
9.5 Research Studies onInulin Safety
A number of preclinical and clinical studies have been done to identify the potential
effect, safety, and adverse effect of inulin. Various ndings have been reported on
the safety of inulin consumption or supplementation. Some clinical studies showed
that inulin consumption may increase the frequency of bowel movements with cer-
tain side effects (Liu etal. 2021).
9.5.1 Clinical Trial Outcome
There is limited data on clinical trials of drug formulations containing inulin.
However, several reports on the use of inulin microparticles, specically Advax as
vaccine adjuvant in different vaccines, indicate that delta inulin was well tolerated
S. K. Gupta and A. Verma
179
and safe (Petrovsky and Cooper 2015; Gordon etal. 2012). The use of these inulin
microparticles in vaccines tested in humans was found to be safe (Anjuomo
etal. 2021).
Guess etal. (2015) performed a randomized controlled trial on 44 subjects with
prediabetes condition. They were supplemented with inulin for 18weeks, and they
were found that inulin produced signicant body weight loss along with a reduction
in intrahepatocellular and intramyocellular lipid (Guess etal. 2015). Another ran-
domized controlled clinical trial on women with overweight and depressive condi-
tions, supplanted with inulin and kept on a calorie-restricted diet, reported that
women show some gastrointestinal complaints such as atulence, gastric discom-
fort, nausea, headache, etc. (Vaghef-Mehrabani etal. 2023). A recent study showed
that inulin supplementation induces muscle biomarkers and increases fat-free mass
(Visuthranukul etal. 2024).
A triple-blind, randomized controlled clinical trial on 49 type 2 diabetic women
was performed to assess the effect of inulin supplementation on blood sugar levels
and oxidative stress. The outcome of the study was that inulin does not produce any
signicant adverse signs in any of the women and showed blood glucose improve-
ment and antioxidant effect (Pourghassem Gargari etal. 2013). Several studies have
reported the side effects and toxic potential of inulin or inulin-based formulation
(Table9.2).
9.5.2 Animal Studies
Acute toxicity studies in animals have shown that inulin is generally well-tolerated,
with no signicant adverse effects observed at normal dietary levels. High doses of
inulin may cause gastrointestinal discomfort, including bloating and atulence, but
these effects are generally reversible (Tawck et al. 2022; Corrêa et al. 2023).
Subchronic and chronic studies in animals have been conducted to assess the safety
of prolonged exposure to inulin. These studies have generally shown a lack of sig-
nicant adverse effects. Inulin has been reported to be noncarcinogenic and non-
mutagenic (Carabin and Flamm 1999). Investigation of the toxicological prole of
inulin was studied by Johannsen (2003). Subacute oral toxicity of a duration of
weeks was performed on a group of rats with different doses of carboxymethylinu-
lin (CMI). The outcome of his ndings suggested that the CMI has no signicant
effect on body weight, food intake, hematological parameters, mortality, and lack of
toxic signs in any organ of the body at the highest dose. The motor activity was not
signicantly altered, and no sign of hypersensitive reactions or allergies has been
reported (Johannsen 2003). One more study was conducted in 9-week-old rats, to
investigate the inuence of dietary bers on microbiota composition, vitamin and
mineral absorption, and metabolic and immune indicators. The nding of this study
indicated that inulin supplementation has benecial effects on intestinal health and
may increase the absorption of minerals by promoting prebiotic activity (Massot-
Cladera etal. 2020). A high dose of inulin administration to the BALB/c mice,
showed an allergic response in ovalbumin (OVA)-sensitized mice, due to excessive
9 Toxicity andSafety Aspects ofInulin
180
Table 9.2 Side effects and safety considerations of some inulin-based formulation
S.
no
Formulation Effect Side effect
Safety
consideration MOA Dose Example Case studies
Reference
1 Inulin
injection
Glycemic
control, weight
management
Injection site
reaction,
hypoglycemia
Use with caution
in patients with
known allergies
to inulin or
related
compounds, and
monitor for sign
of allergies
reaction during
drug
administration
Modulates insulin
sensitivity and
glucose
metabolism and
acts as a plasma
volume expander,
increasing
intravascular
volume
Dosage
varies
based on
indication
and
patient’s
condition
Insuman
inulin
Patients with type
2 diabetes
experienced
improved
glycemic control
and weight loss
Wang
etal.
(2019)
2 Inulin
powder
Prebiotic
effects,
digestive health
Bloating,
atulence,
diarrhea
Start with low
doses and
increase
gradually to
minimize
gastrointestinal
discomfort, use
with caution for
gastrointestinal
disorder
Promotes helpful
gut bacteria,
enhances gut
health, acts as a
prebiotic
5–20g/
day
Beneo
Orafti
inulin
powder
Elderly
individuals
showed improved
bowel function
and reduced
constipation with
daily inulin
powder
supplementation
Watson
etal.
(2019)
3 Inulin
capsule
Weight
management,
gut health
Gastrointestinal
discomfort,
diarrhea
Take with plenty
of water; avoid in
individuals with
g.i.t. disorders,
start with low
doses and
increase
gradually
Promotes satiety,
decreases calorie
absorption, and
enhances the
composition and
function of the
gut microbiota
2–6g/day Inulex
lnulin
capsules,
ber
choice
inulin
capsules
The patient
experienced
reduced appetite
and improved
weight
management with
inulin capsule
supplementation
Jenko
Pražnikar
etal.
(2023)
S. K. Gupta and A. Verma
181
4 Inulin syrup Digestive
health, bowel
regularity
Nausea,
vomiting,
abdominal pain,
atulence
Use cautiously in
individuals with
fructose
intolerance or
sensitivity
Enhances bowel
motility, stool
consistency,
satises appetite,
and aids in
weight loss
10–30g/
day
Inulinex
syrup
Patients with
constipation
reported improved
bowel movements
and reduced
laxative use with
inulin syrup
Chang
etal.
(2023)
5 Inulin tablet Glycemic
control, lipid
metabolism
Stomach upset,
indigestion,
diarrhea, loose
stools
Monitor for
gastrointestinal
symptoms, avoid
in patient with
digestive disorder
and hydration
status, especially
in the elderly
Enhances insulin
sensitivity and
lipid prole by
modifying
glucose and lipid
metabolism
2–10g/
day
Inulin
plus
tablets
Diabetic patient
showed improved
blood sugar and
cholesterol level
with inulin tablet
supplementation
Paquette
etal.
(2023)
6 Inulin or
sinistrin
injection
As polymer in
food and
pharmaceutical
industries
Serious
hypersensitivity
reactions
The French
National Agency
for the Safety of
Medicines and
Health Products
(ANSM)
withdraw
products
containing inulin
and its analogue
Serious
hypersensitivity
reactions
– Injection Most adverse
reactions to inulin
and sinistrin are
hypersentivity
reactions
Bui etal.
(2021)
9 Toxicity andSafety Aspects ofInulin
182
accumulation of short-chain fatty acid (SCFA), and this study highlighted the per-
sonalized use of inulin-based products (Xie etal. 2023). Pauly etal. studied the
effect of short-term inulin-supplementation in the hepatic cholesterol and bile acid
metabolism in mice, and their ndings indicated that inulin can disturb the hepatic
metabolism and function (Pauly etal. 2020).
9.5.3 In Vitro Studies
Shang etal. performed invitro antioxidant activity of inulin by using DPPH radical
scavenging assays. The inulin-produced concentration dependency increased in
DPPH radical scavenging activities, but it was reported as a weak antioxidant
(Shang etal. 2018). Carabin and Flamm mentioned in their study that many invitro
studies reported that inulins do not have any mutagenic or genotoxic effects (Carabin
and Flamm 1999). Findings from both invivo and invitro research demonstrate that
consuming inulin-type fructans promotes the synthesis of SCFA (Moser etal. 2015).
One more invitro study was performed by Gunn etal. in 2022 and reported that
psyllium supplementation can reduce the gas production caused by the intake of
inulin, especially in individuals with inammatory bowel syndrome (IBS). They
used fecal samples from some patients with IBS and examined the invitro effect of
inulin and psyllium on the fermentation model (Gunn etal. 2022). A recent study on
the effect of inulin supplementation on obesity has been conducted. The ndings of
the invitro study indicated that the metabolites of Bidobacterium can utilize inulin
and decrease the level of cytokines and TNF-α, indicating its anti-inammatory
potential. Inulin promotes fat-free muscle production and decreases systemic
inammation (Visuthranukul etal. 2024). Much of the data is not available on
invitro studies of inulin related to its assessment of its safety and toxicity, and there-
fore there is a need for research to assess the safety and toxicity properties of inulin.
9.6 Future Prospects
The future prospects regarding the safety and toxicity of inulin appear to be promis-
ing. Inulin, a natural dietary ber found in many plants, is widely recognized for its
prebiotic properties and health benets. Studies have shown that inulin-type fruc-
tans, even when consumed at high levels, do not result in signicant adverse effects
such as mortality, morbidity, target organ toxicity, reproductive or developmental
toxicity, or carcinogenicity. In terms of safety, inulin is reported as safe for use in
foods by many legal authorities worldwide, and as a food ingredient, it can be used
without restriction in food formulation. However, at high doses, some individuals
may experience increased gastric discomfort due to osmotic pressure, and it may
vary from person to person. Inulin has a variety of applications in the pharmaceuti-
cal industry due to its unique and exible structure, which makes it an excellent
carrier for drug delivery.
S. K. Gupta and A. Verma
183
9.7 Conclusion
Inulin, a type of ber, has been widely used in human diets for centuries due to its
safety and gastrointestinal tolerance. However, recent studies have shown that high
intake of inulin can cause gastric distress, bloating, and changes in hepatic bile acid
metabolism. Inulin consumption can also cause cholestasis and negatively impact
liver function. Some individuals may experience digestive discomfort, irritable
bowel syndrome, and diarrhea due to its fermentable nature. Inulin can also increase
plasma cholesterol levels and exacerbate atherosclerosis. Some individuals may
experience allergic reactions, and it is important to seek medical attention if a reac-
tion is suspected. Inulin-type dietary supplementation should be person-specic to
ensure safe and effective health benets. It is generally safe for most people but may
cause adverse effects like bloating, constipation, cramps, back pain, and headache.
Therefore, toxicity and safety considerations are important while using or develop-
ing inulin-based pharmaceutical products.
Acknowledgments The authors are obliged to the Chairman and Group Director, Rungta College
of Pharmaceutical Sciences and Research, Bhilai, for providing support in every possible form. We
also acknowledge the Central Research Committee, SRGI, Bhilai, for providing the facility to pol-
ish the book chapter language.
ContributionsAll authors made signicant contribution in writing the manuscript, and all
authors have approved the nal version of the manuscript.
Declaration of Competing Interest The authors do not have any conict of interest to declare.
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