Chitosan safety and side effects -
In various studies, chitosan has been safely used for up to 12 to 13 weeks. Aside from possible side effects, chitosan may not be right for everyone.
Because one of the main sources of chitosan is crustaceans, people with a shellfish allergy should avoid using it. Anyone with a mushroom allergy should also avoid chitosan sourced from fungi. It's recommended that people who are pregnant or breastfeeding avoid using chitosan. This is due to the lack of safety information regarding chitosan use in these populations.
More information is needed to determine the full safety profile of chitosan supplements. Dietary supplements are not regulated like prescription medications in the United States.
Therefore, some may be safer than others. When choosing a supplement , consider factors such as third-party testing, potential drug interactions, and other safety concerns. Talk to a healthcare provider or a registered dietitian nutritionist RD or RDN about supplement quality and safety.
Currently, there are no dosage guidelines for chitosan supplements. In clinical trials, chitosan dosing ranged from 0. Chitosan was also commonly used for 12 to 13 weeks in the trials. It's recommended that you follow dosage directions as indicated on the supplement label.
You can also obtain dosage recommendations from a healthcare provider. Chitosan may negatively interact with certain medications, supplements, or nutrients. These interactions may block the absorption or proper use of chitosan or the medications, supplements, or nutrients it is taken with.
There is concern that chitosan interacts with medications and supplements that may have similar uses. These medications and supplements include:.
Chitosan may also reduce the absorption of fat-soluble vitamins. However, this was only seen in animal studies. This may occur when chitosan binds to fatty substances in the digestive tract before being absorbed into the bloodstream.
It should be noted that there isn't solid evidence or clear documentation of these or other interactions for chitosan. However, it's best to be cautious and talk with a healthcare provider before using chitosan to discuss potential interactions, especially if you use any medications or supplements.
It is also important to carefully read the ingredients list and nutrition facts panel of a supplement to know which ingredients and how much of each ingredient is included. Please review supplement labels with a healthcare provider to discuss any potential interactions with foods, other supplements, and medications.
Various foods and supplements contain chitosan. Compared to chitosan-containing foods, supplements may be easier to access and appear to be a more popular method for consuming the polysaccharide.
The main food sources of chitosan include crustaceans and certain types of mushrooms. Chitosan may also come from the exoskeleton of insects. In crustaceans and mushrooms, chitosan is found in its original form of chitin recall that chitosan is a derivative of chitin.
Specifically, chitin is a part of the exoskeleton of crustaceans and the cell walls of some mushrooms and other fungi.
The only way to consume chitin that comes from crustaceans is through dietary supplements. This is because the exoskeletons of shrimp, crabs, lobsters, and other crustaceans are not commonly eaten.
Chitin has been found in both edible and nonedible mushrooms. However, an enzymatic reaction has to occur for chitin to be converted to chitosan. Chitosan is considered to be more easily digested than chitin.
Supplements tend to be a better option for getting chitosan. Due to their popularity, chitosan supplements are not difficult to find.
There are a number of websites that sell chitosan supplements. You can also find chitosan supplements in certain retail stores, grocery stores, or specialty nutrition shops.
Chitosan supplements come in many forms, including capsules, powders, and tablets. There are also topical chitosan options, like gels. Some chitosan supplements may be mixed with other nutrients, herbs, or ingredients. Be sure to read the full list of ingredients to understand the product you purchase.
Many chitosan supplements are sourced from crustaceans. If you are vegan or vegetarian, look for chitosan that has been sourced from mushrooms instead. Of course, you shouldn't use chitosan products if you're allergic to any of the ingredients.
For example, if you have a shellfish allergy, then you should avoid using chitosan supplements that come from crustaceans. Several chitosan supplements on the market can fit other diets, like a gluten-free diet or an organic diet.
This information should be listed on the label or packaging of the supplement. Chitosan is a derivative of chitin, a polysaccharide present in the exoskeletons of crustaceans, certain insects, and the cell walls of fungi.
Chitosan contains nutrients and bioactive compounds that may be useful for high blood sugar, high blood pressure, wounds, and other conditions. In general, more research is needed on chitosan to prove its benefits. Side effects are possible when taking chitosan, so talk with a healthcare provider to make sure it's the right supplement choice for you.
Some chitosan products contain common allergens , like shellfish. Other chitosan products are made from mushrooms. Avoid using chitosan if you're allergic to shellfish, mushrooms, or any other substance in the ingredients list.
You should talk with a healthcare provider about using chitosan if you're pregnant or breastfeeding. There isn't much research on the use of chitosan in these populations, so it may be best to avoid it.
To get chitosan naturally, you'd need to eat foods that contain chitin. Chitin-containing foods include mushrooms and crustaceans. However, chitin is only available in the exoskeletons of crustaceans, a part of the animal that isn't typically eaten.
Chitosan is most commonly found in supplements. This is because a chemical reaction is needed to transform chitin from foods into chitosan. When using chitosan supplements, you can take them daily. However, little is known about the safety of using chitosan for more than 12 weeks.
Therefore, it might not be safe to take chitosan for more than 12 weeks. Aranaz I, Alcántara AR, Civera MC, et al. Chitosan: an overview of its properties and applications. Polymers Basel. Moraru C, Mincea MM, Frandes M, Timar B, Ostafe V.
A meta-analysis on randomised controlled clinical trials evaluating the effect of the dietary supplement chitosan on weight loss, lipid parameters and blood pressure. Medicina Kaunas.
de Queiroz Antonino RSCM, Lia Fook BRP, de Oliveira Lima VA, et al. Preparation and characterization of chitosan obtained from shells of shrimp Litopenaeus vannamei Boone.
The randomisation codes were kept in an individually sealed, opaque envelope and broken only after the completion of data lock procedures. The chitosan used in the study was chitosan derived from Aspergillus niger.
Each capsule of KiOnutrime-CsG® contained mg chitosan with excipients magnesium stearate and colloidal silicone dioxide.
In case of placebo, chitosan was replaced with mg microcrystalline cellulose powder and the excipients were colloidal silicone dioxide, colour yellow oxide ofiron and colour natural caramel in order to match KiOnutrime-CsG® colour. Each bottle of study medication contained 75 capsules for total 15 days administration.
Subjects were instructed to take one capsule in the morning, 2 capsules 15 min before lunch and 2 capsules 15 min before dinner with a glass of water.
They were instructed to fill up the time of drug administration and the number of capsules taken in the subject diary. Subjects were also instructed to visit the study centre every 15 days to receive new medication containers and to assess medication compliance from the subject diary.
Dosage compliance was assessed counting the unused quantity of medication from returned bottles. Subjects were also advised to maintain their normal routine diet and to record the type and amount of food consumed for periods of 5 days between days 1—5, days 41—45 and days 86—90 in the food diary provided, to calculate and analyse the daily caloric value.
At each study visit except randomisation visit, demographic data, anthropometric determinations includes upper abdominal circumference, hip circumference, waist circumference and waist to hip ratio , body composition BMI, body fat, visceral fat, muscle mass , HbA1c, lipid parameters triglyceride, HDL, LDL, VLDL , and biochemistry data urea, serum creatinine, SGPT, SGOT were evaluated to determine safety and efficacy of KiOnutrime-CsG®.
Physical examinations and vital signs radial pulse, blood pressure, respiratory rate, and body temperature were carried out at all visits. Body weight and body composition parameters were measured using calibrated Body Fat Monitor Tanita Corporation, Japan; Model BC , which assesses body composition indirectly by multifrequency bioelectrical impedance analysis.
Anthropometric determinations were made using non-stretch measuring tape to the nearest 0. Fasting blood was collected onsite and then transferred within 30 min to central pathology laboratory Dr Lal Pathlabs at Ahmedabad and Bangalore, India.
Serum samples were separated rpm, 15 min, 4 °C , immediately frozen and stored at ° C until analysed. All analyses were completed within 12 h of blood collection and all methods were validated by three freeze-thaw cycles.
Study participants also completed a SF Short Form 36 health-related quality of life QoL questionnaire [ 27 , 28 ] at each visit except the randomisation visit.
The questionnaire consisted of eight multi-item dimensions. They were physical functioning PF , limitations due to physical problems Role-Physical , vitality VT , bodily pain BP , social functioning SF , limitations due to emotional problems Role-Emotional , mental health MH , and general health GH.
The scores from these dimensions were further grouped into physical and mental components expressed as Physical Component Summary PCS and Mental Component Summary MCS scores.
The PCS score reflected physical morbidity and adaptation to disease, whereas the MCS score referred to mental morbidity and adaptation.
This was assessed by an independent dietician. The average calorie intake for the period of day 1—5, day 41—45 and day 86—90 was calculated for both the groups. The primary efficacy end point was reduction in body weight in kilograms on day 45 and day 90 compared to baseline.
Secondary outcome measures include mean changes in body composition data BMI, body fat, visceral fat, muscle mass , anthropometric values change in upper abdominal circumference, hip circumference, waist circumference and waist to hip ratio , lipid profile and HbA1c levels. Safety was evaluated by clinically and physically observing and reporting adverse events AE and assessing changes in vital signs, and biochemistry parameters.
Change in SF QoL scale from baseline was also assessed to evaluate safety and efficacy of KiOnutrime-CsG® capsules. The sample size of this study was based on the primary objective of reduction in the body weight after 90 days treatment with chitosan.
All the statistical analyses were carried out using SAS v9. The distribution of the variables was investigated using the Kolmogorov-Smirnov test.
To evaluate the effect of chitosan capsules on the investigated variables, P value for between groups comparison was calculated using unpaired t- test or Mann Whitney test based on the distribution of data. In case of within group comparison, data were analysed using paired t -test or Wilcoxon test depending upon the distribution of data.
P values of less than 0. Of the subjects screened, a total of 96 subjects were enrolled in the study. Of these, 64 subjects were randomly assigned to the chitosan group and 32 to the placebo group. Five subjects from chitosan group and one from placebo group were lost to follow-up; while three subjects from chitosan group and one from placebo group withdrew their consent during the course of the study.
A total of 86 subjects completed the study. Figure 1 describes the disposition of the study subjects. There was no significant difference between the baseline demographics of study participants in each treatment group Table 1.
A total of 15 subjects in chitosan group and 6 subjects in placebo group had hypertension, diabetes mellitus, dyslipidemia or their combination.
Reduction in the mean body weight over a period of 45 and 90 days intervention for chitosan and placebo group was assessed. In chitosan group, body weight was reduced from While in placebo group the body weight was While in the placebo group, the percentage of subjects who reduced body weight in the same range was Only about 6.
In chitosan group, the mean change in body weight was Table 2 shows the comparison between body weights in both the groups. Table 3 describes the absolute values of each study parameters at baseline, at day 45 and day 90 and Table 4 describes the change in each parameter at day 45 and day 90 from baseline.
Mean change in the reduction of BMI from baseline was significantly higher in chitosan group on day 45 and day 90 as compared to subjects receiving placebo Table 4. In chitosan group the mean changes in BMI at day 45 were found to be in the range of After 90 days of administration, there was a further reduction in BMI in chitosan group which was in the range of However, there was no statistical difference between both treatments at any time points.
Mean changes in body fat reduction from baseline in chitosan group as compared to placebo group at day 45 This mean change in body fat reduction was in the range of This further decreased to 9. In placebo group, however, visceral fat remained unchanged at day 45 Again, when compared between treatments, the values were statistically non-significant.
We found that muscle mass decreased in chitosan group This can also be observed by reduction of muscle mass in the range of The reduction in body weight caused a comparable decrease in anthropometric measurement as well.
On the contrary, there was no statistical significant reduction in upper abdominal circumference, hip circumference and waist circumference in patients treated with placebo on day 45 and day Mean change in reduction from baseline in upper abdominal circumference There was no significant change in waist to hip ratio in both treatment groups at day 45 and day 90 HbA1c level at baseline was compared with post-administration measurements at day 45 and day 90 to assess the efficacy of chitosancapsules.
In this study, HbA1c level was significantly decreased at day 45 5. After 90 day treatment with chitosan, HbA1c level significantly decreased in those17 subjects mean: 6. This shows that chitosan was effective in reducing HbA1c levels in subjects who were having higher glycaemic value initially, while subjects with normal glycaemic levels were unaffected.
Analysis of daily food intake for the period of 15 days day 1—5, day 41—45 and day 86—90 for calorie intake showed there was no significant change, in either group, during this study. The mean caloric intake in chitosan group for day 1—5 was kcal, for day 41—45 was kcal and for day 86—90 was kcal.
While the same for placebo group was kcal, kcal and kcal, respectively. Lipid levels in both treatment groups are described in Table 5. Although LDL levels increased in chitosan group at day 45 and in placebo group at day 90, in general the results were clinically non-significant as this increase in LDL can be attributed to only two of the subjects; one in chitosan group and one in placebo group who showed transient increase in their LDL levels.
The SF analysis shows that the mean PCS score and mean MCS score obtained in chitosan group at day 0 were The mean PCS score and mean MCS score obtained in placebo group at day 0 were There were a total of 10 adverse events AEs recorded during the study period: four in placebo group and six in chitosan group.
In chitosan group reported AEs were common cold, hypertriglyceridemia, body ache, constipation 2 subjects and hypertension, while in placebo group, the reported AEs were mild headache 2 subjects , hypertriglyceridemia and fracture. All adverse events were mild in nature and unrelated to the study treatment.
There was no statistically significant difference in laboratory parameters SGOT, SGPT, serum creatinine and urea from baseline to day 90 in both chitosan and placebo groups.
No dropout was observed due to AEs, which states that overall the study treatment was safe and well tolerated by all study subjects. The observed weight loss in chitosan group is in contrast to only 0. Although some studies demonstrated that reduction in body weight by administration of chitosan can be achieved in individuals given a hypocaloric or standardized diet [ 14 , 29 ], other studies show efficacy of chitosan for persons without diet restrictions [ 10 , 23 , 30 , 31 ].
The results of our study confirm that indeed significant weight loss can be achieved in subjects adhering to a non-restrictive diet [ 10 , 23 , 30 , 31 ]. Reasons for the difference in results in our study with other reported studies could be difference in diets, dosage and timing of chitosan administration or protocol variability such as life style recommendations.
One factor which is important to consider is the timing of chitosan ingestion before meals. It is typically recommended that chitosan supplements be ingested approximately 15 min to 1 h prior to a meal in order to allow sufficient time for chitosan to dissolve in the stomach acid[ 18 ].
In our study, the dosage was one capsule 15 min before breakfast and two capsules each 15 min before lunch and dinner. This allowed sufficient time for it to dissolve properly and efficiently bind the fats present in the meal, which resulted in observed weight loss.
Body weight gain and increase in BMI are the key clinical features of obesity. BMI correlates fairly well with total body fat on a population basis [ 32 ]. The overweight BMI In this study we found that after 90 day administration with chitosan, there was It is well known that weight reduction in subjects with obesity has a marked effect on the regulation of lipolysis [ 33 ] and weight loss shows good correlations with several of the circumferences [ 34 ] that were measured in present study.
Also, in one of the gastric bypass study conducted by Sjostrom and colleagues [ 35 ], it was found that the profound weight loss experienced by the subjects resulted from a global decrease in body fat rather than localised loss. Also, hypocholesterolemic properties of chitosan decrease the risk of atherosclerosis and other cardiovascular dysfunctions [ 36 ].
Chitosan, by the virtue of its property to bind fat and triglycerides, may also have caused the disturbances in regulation of lipolysis resulting in lowering of body fat and visceral fat observed in our study. Reduction of muscle mass by chitosan was observed in this study which is reduced in an average of 0.
Although there is a statistically significant reduction, this has not produced any clinically relevant adverse effects over a period of 90 days. It is already reported that chitosan can regulate lipids with benefit on anthropometric parameters [ 37 ].
Also, in one of the study conducted over a period of five years, it was confirmed that weight gain and weight loss are associated with changes in the anthropometric measurements and waist to hip ratio WHR in both genders [ 38 ]. The reduction in body composition and anthropometric parameters observed in our study can be attributed to general reduction in body weightpossibly due to reduction in fat absorption [ 39 ] by chitosan.
Practically no significant change was observed in serum triglyceride, LDL and VLDL throughout the test period while HDL was slightly increased in chitosan group non-significant. It is well known that Low-density lipoproteins LDL are considered as important risk factors for cardiovascular diseases CVD , while highdensity lipoproteins HDL are well recognized for their putative role in reverse cholesterol transport [ 40 ].
Since HDL-cholesterol is more metabolisable into bile acid than LDL-cholesterol [ 41 ], it is presumed that a deficiency of bile acid in the body due to binding with chitosan would accelerate the conversion of cholesterol to bile acid, which may result in an increase of HDL-cholesterol.
Obesity is a multi-factorial disorder, which is often associated with many other significant diseases such as diabetes, inflammation, hypertension and other cardiovascular diseases; there is a consistent graded relationship between increased BMI and prevalence of non-insulin dependent diabetes mellitus NIDDM and insulin resistance [ 43 ].
It is established that inflammation, diabetes and obesity are interrelated and a person with diabetes are predisposed to obesity and metabolic syndrome. HbA1C reflects the long-term glycaemic level and is a marker for progression of diabetes.
It has been reported that chitosan significantly reduced postprandial blood glucose levels in both animal and in vitro models [ 44 ] as well as in humans [ 45 ]. This may the reason for the observed decrease in HbA1c levels in our study. Interestingly, this reduction was mainly observed in subjects who were initially having high HbA1C levels, while subjects with normal HbA1C levels at baseline were unaffected by chitosan.
However, more clinical studies are required to confirm this effect of chitosan in large diabetic population. The results of SF QoL score showed that there was significant improvement in mean PCS score in chitosan group which reflects improvement in physical morbidity and adaptation to obesity.
However, mean MCS score failed to improve with the treatment. This may be due to failure to evaluate the impact that excess weight would have on obesity-specific aspects of QoL score during the baseline evaluations [ 46 ].
This might explain why no effect of decrease in BMI was detected on MCS despite it being recognised that people who are overweight or obese are more likely to suffer from discrimination and depression [ 47 ].
In summary, we conclude that KiOnutrime-CsG® capsule, containing mg of chitosan from fungal origin, was able to reduce the mean body weight up to 3 kg during the days study period. KiOnutrime-CsG® capsulewas also found to be safe and well tolerated by all study participants.
Sengupta K, Mishra AT, Rao MK, Sarma KV, Krishnaraju AV, Trimurtulu G. Efficacy and tolerability of a novel herbal formulation for weight management in obese subjects: a randomized double blind placebo controlled clinical study.
Lipids Health Dis. Google Scholar. Nammi S, Koka S, Chinnala KM, Boini KM. Obesity: an overview on its current perspectives and treatment options. Nutr J. Article Google Scholar. Taylor RW, Keil D, Gold EJ, Williams SM, Goulding A. Body mass index, waist girth, and waist-to-hip ratio as indexes of total and regional adiposity in women: evaluation using receiver operating characteristic curves.
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Brenot F, Herve P, Petitpretz P, Parent F, Duroux P, Simonneau G. Add everything up to see the total daily dose. When looking for a supplement, always verify that it has been third-party tested.
Third-party testing ensures that the supplement meets certain purity and potency standards. Look for a seal on the packaging from an organization such as NSF International , USP , or ConsumerLab.
These seals are typically good indicators of supplement quality. Talk with a healthcare professional before taking a chitosan supplement. If weight loss is your goal, they may be able to provide more personalized recommendations that are better suited for that purpose.
Chitosan is a widely available supplement promoted for weight loss. While some research indicates that it may be somewhat effective in conjunction with a calorie-restricted diet and exercise, more research is needed 2 , 8.
Always proceed with caution when starting a new supplement regimen, and ensure that the benefits outweigh the potential risks.
Where chitosan is concerned, its benefits for weight loss are inconclusive. Try this today: Sustainable weight loss is best achieved through a whole-food diet , physical activity, and — importantly — social support. Our experts continually monitor the health and wellness space, and we update our articles when new information becomes available.
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It may also be taken as a supplement to help boost exercise performance, lower blood…. A Quiz for Teens Are You a Workaholic? How Well Do You Sleep? Health Conditions Discover Plan Connect. Nutrition Evidence Based Shells for Weight Loss? Medically reviewed by Adrienne Seitz, MS, RD, LDN , Nutrition — By Molly Knudsen, MS, RDN on September 7, What is chitosan?
Chitosan safety and side effects is a Chitosan safety and side effects Chotosan intended Chitodan health professionals. For a general Importance of reducing sodium intake, see our consumer fact sheet. More than hCitosan of adults and almost one-third of children and adolescents in the United States are overweight or have slde [ 1Chitosan safety and side effects ]. Health experts anv that making lifestyle changes—including following a healthy dietary pattern, reducing caloric intake, and engaging in physical activity—is the basis for achieving long-term weight loss [ ]. However, because making diet and lifestyle changes can be difficult, many people turn to dietary supplements promoted for weight loss in the hope that these products will help them more easily achieve their weight-loss goals. Dietary supplements promoted for weight loss encompass a wide variety of products and come in a variety of forms, including capsules, tablets, liquids, powders, and bars [ 11 ]. Manufacturers market these products with various claims, including that these products reduce macronutrient absorption, appetite, body fat, and weight and increase metabolism and thermogenesis. Chitosan Chktosan a form of fiber wffects processed from Effecte shells. Endurance nutrition plan Chitosan safety and side effects forms of fiber, such as oat bran, chitosan is not well digested by the human sixe. As it passes through sied digestive tract, it seems to have an ability to bond with ingested fat and carry it out in the stool. For this reason, it has been tried as an agent for lowering cholesterol and reducing weight. However, the results in studies have been more negative than positive. In addition, chitosan has been tried as a treatment for kidney failure and as an aid in wound healing.
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