After 90day treatment with chitosan, HbA1c level significantly decreased in those17 subjects (mean: 6.04%; range: 5.1 to 6.8%) while in the remaining subjects, it was unchanged throughout the study period (mean: 5.48%; range: 4.7 to 5.9%). The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. However, more clinical studies are required to confirm this effect of chitosan in large diabetic population. Hypocholesterolemic Effect of Chitosan in Adult Males. Ventura P. Lipid lowering activity of chitosan, a new dietary integrator. Serum samples were separated (4000rpm, 15min, 4C), immediately frozen and stored at -20 C until analysed. One such substance which acts by reducing the dietary absorption of fat is chitosan. Taylor RW, Keil D, Gold EJ, Williams SM, Goulding A. Figure1 describes the disposition of the study subjects. Curr Pharm Des. 2004;117(1207):U1211. 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]. Effect of a new chitosan dietary integrator and hypocaloric diet on hyperlipidemia and overweight in obese patients. Acta Toxicologica et Therapeutica. The effects of chitosan oligosaccharide (GO2KA1) supplementation on glucose control in subjects with prediabetes. This may the reason for the observed decrease in HbA1c levels in our study. 1978;84(1):17. Correspondence to Eur J Clin Nutr. The mean caloric intake shows that there was no change in dietary habits of subjects in both groups. The exclusion criteria were history of surgical procedure(s) in the past 6months, history of invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) within the past one year, history of subcutaneous injections (e.g., heparin, insulin) within the past one month, subject on stable dose of metformin, pioglitazone or on glucagon-like peptide analogues, subjects with history of bleeding disorder, subjects with history of allergy to chitosan, subjects with treatment of fat soluble vitamins and minerals or other dietary aids, subjects with poorly controlled diabetes mellitus or hypertension, subjects having inflammatory diseases of the gastrointestinal tract, female subjects who are pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period, or is breast feeding or in preparations used in the treatment of menopause disorders and subjects who are taking or has taken diet pills or supplements within the past 30days. Body weight and body composition parameters were measured using calibrated Body Fat Monitor (Tanita Corporation, Japan; Model BC 601), which assesses body composition indirectly by multifrequency bioelectrical impedance analysis. 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. Cookies policy. 1978;31(5):76973. The properties of chitosan are similar to cellulose [12]. In concert with this, there was also reduction in body composition and anthropometric parameters together with improvement in QoL score. Results from the Third National Health and Nutrition Examination Survey. 2004;3:3. https://doi.org/10.1186/s12937-016-0122-8, DOI: https://doi.org/10.1186/s12937-016-0122-8. Results were expressed as meanstandard deviation (SD). 2015;2(25):0150053. doi: 510.1177/0003319713493126. A total of 15 subjects in chitosan group and 6 subjects in placebo group had hypertension, diabetes mellitus, dyslipidemia or their combination. Rizzo M, Perez-Martinez P, Nikolic D, Montalto G, Lopez-Miranda J. This mean change in body fat reduction was in the range of -6.60 to +2.80% and -6.80 to +2.60% in chitosan group, while in placebo group it was -3.70 to +2.80% and -2.70 to +2.30% at day 45 and day 90, respectively. Chitosan is a popular dietary fibre often used to prevent dietary fat absorption as a means for controlling weight. There was significant mean reduction in upper abdominal circumference, hip circumference and waist circumference at day 45 (p<0.0001) and day 90 (p<0.0001) from baseline in subjects treated with chitosan capsules (Table3). Am J Clin Nutr. Nutr J. Weight loss clinical trial outcomes, however, have contradictory results regarding its efficacy. HbA1c level at baseline was compared with post-administration measurements at day 45 and day 90 to assess the efficacy of chitosancapsules. Kopelman PG. 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. 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]. 2014;20(40):624955. J Am Nutraceut Assoc. Article But when mean changes in muscle mass from baseline was compared, it was found that at day 90 there was significant difference (p=0.0008) between the groups (-0.741.57 vs. -0.081.16). The overweight (BMI 25.0 to 29.9kg/m2) and obese (BMI 30kg/m2) individuals have higher body fat together with increased risk of cardiovascular and other metabolic disorders. Again, when compared between treatments, the values were statistically non-significant. 1995;19(6):S9S12. 1995;16(4):21530. KiOnutrime-CsG (KitoZyme, Belgium) is a non-animal chitosan obtained from the cell walls of the non-genetically modified Aspergillus niger mycelium, a by-product of citric acid production. 1993;17(3):S412. Int J Obes Relat Metab Disord. 1994;18(6):397404. The chitosan used in the study was chitosan derived from Aspergillus niger. KiOnutrime-CsG is an alternative to crustacean-derived chitosan. Abelin J, Lassus A. L-112 Biopolymer - Fat binder as a weight reducer in patients with moderate obesity. Ware JE, Kosinski M, Kellar SD. Lipids Health Dis. There was no significant change in waist to hip ratio in both treatment groups at day 45 and day 90 (-0.00270.02 and -0.0010 0.02 vs. -0.00350.01 vs.-0.00330.01 at p=0.091 and 0.768). Emerging approaches for the treatment of hypertriglyceridemia. P values of less than 0.05 were considered as statistically significant difference between and within treatment groups. A randomized, double-blind, placebo-controlled study examining the effects of a rapidly soluble Chitosan dietary supplement on weight loss and body composition in overweight and mildly obese individuals. Further analysis revealed that, there were 17 subjects whose HbA1c levels were above 6% (mean: 6.55%; range: 6 to 8.2%) while the remaining subjects had HbA1c levels below 6% (mean: 5.47%; range: 4.3 to 5.9%) at baseline. Chitin. 2015;26(3):135. doi: 110.1007/s10856-10015-15461-z. 1995;16(4):199214. Another possible explanation may be that people who are very overweight and obese may need to loose in excess of 10% of their body weight in order to experience a positive impact on QoL [48]. 1. PHZ participated as investigator in the study, involved in subject recruitment, their compliance and acquisition of the data. Study subjects were randomized in a 2:1 ratio to receive chitosan (KiOnutrime-CsG capsules) or indistinguishable placebo capsules. The PCS score reflected physical morbidity and adaptation to disease, whereas the MCS score referred to mental morbidity and adaptation. The questionnaire consisted of eight multi-item dimensions. Physical examinations and vital signs (radial pulse, blood pressure, respiratory rate, and body temperature) were carried out at all visits. 2004;28(9):114956. 2001;3(6):40510. LDL and HDL subfractions, dysfunctional HDL: treatment options. ORahilly S. Science, medicine, and the future. 1989;119(8):11006. 1997;21(8):61925. Changes in measurements of body fat distribution accompanying weight change. Int J Obes Relat Metab Disord. Br Heart J. N Z Med J. Lipids. 1996;17:5370. Medication compliance was considered reached when there was 90% capsules intake over a period of 90days capsules administration. 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. Also, short form-36 quality of life (QoL) questionnaire was assessed to evaluate improvement in life-style and dietary habits were recorded for calorie intake. Change in SF-36 QoL scale from baseline was also assessed to evaluate safety and efficacy of KiOnutrime-CsG capsules. 1998;67(1):449. 1993;306(6890):143740. However, most of the randomised double-blind placebo-controlled trials have reported that it may decrease body weight and serum lipids [10, 2023, 25, 26] while a few studies have found no effect of chitosan on clinical outcomes [12, 24]. Part of Kanauchi O, Deuchi K, Imasato Y, Kobayashi E. Increasing Effect of a Chitosan and Ascorbic Acid Mixture on Fecal Dietary Fat Excretion. Int J Obes Relat Metab Disord. Subjects of both genders were screened based on inclusion criteria and were included in the trial if they were aged 18 to 65years, who expressed interest to participate in the study, had BMI between 26 and 35 (both inclusive), willing to comply with the study schedule and procedure. Visceral fat significantly decreased (p<0.0001) in subjects administered with chitosan at day 45 (10.473.38%) from baseline (10.803.52). 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]. Expert Opin Pharmacother. Ethicare Clinical Trial Services, Titanium City Centre, 100 Feet Road, Ahmedabad, 380015, Ahmedabad, India, KITOZYME, Parc Industriel des Hauts-Sart, Zone 2, Rue de Milmort 680, 4040, Herstal, Belgium, Poojan Multispecialty Hospital, Gurukul Road, Memnagar, Ahmedabad, 380052, India, DHL Research Centre, Nr. J Mater Sci Mater Med. While the same for placebo group was 1761kcal, 1701kcal and 1677kcal, respectively. Reduction of muscle mass by chitosan was observed in this study which is reduced in an average of 0.74kg over a period of 90days. However, their use is controversial as these pharmacotherapies are known to have significant adverse effects [6, 7] and a consensus on the optimal clinical use of these pharmacological agents is not fully established yet, and additional large clinical studies are needed [8]. Analysis of daily food intake for the period of 15days (day 15, day 4145 and day 8690) for calorie intake showed there was no significant change, in either group, during this study. Nutr J 15, 3 (2015). 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]. JVT participated as investigator in the study, involved in subject recruitment, their compliance and acquisition of the data. VR Trivedi. 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. The primary efficacy end point was reduction in body weight in kilograms on day 45 and day 90 compared to baseline. Efficacy was assessed by measuring body weight, body composition parameters, anthropometric measurements, HbA1C level and lipid profile at day 45 and day 90. 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). 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. Kaukua JK, Pekkarinen TA, Rissanen AM. 1993;70(6):53741. 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. 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. Of these, 64 subjects were randomly assigned to the chitosan group and 32 to the placebo group. Obesity: an overview on its current perspectives and treatment options. Treatment of obesity includes lifestyle-based intervention (diet, exercise, and behaviour therapy) and medical or surgical intervention (pharmacotherapy or bariatric surgery). 2013;14(7):1421424. Each bottle of study medication contained 75 capsules for total 15days administration. 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. The results of SF-36 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. The study protocol and protocol-related documents were approved by the institutional ethics committee of each site before initiating any trial related activity. In case of placebo, chitosan was replaced with 500mg 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). This was a 90days, phase IV, randomised, multicentre, single-blind, placebo-controlled, clinical study conducted at four hospital sites in cities of Ahmedabad and Bangalore in India. Fasting blood was collected onsite and then transferred within 30min to central pathology laboratory (Dr Lal Pathlabs at Ahmedabad and Bangalore, India). Mean change in reduction from baseline in upper abdominal circumference (-0.921.25 and -2.171.98 vs. -0.350.95 and -0.501.10), hip circumference (-1.051.05 and -2.071.51 vs. -0.411.14 and -0.661.24) and waist circumference (-0.911.68 and -1.972.20 vs. -0.641.22 and -0.901.47) was significantly (p<0.0001) greater in subjects treated with chitosan than with placebo at day 45 and day 90, respectively (Table4). Rizzo M, Giglio RV, Nikolic D, Patti AM, Campanella C, Cocchi M, et al. Non-insulin dependent diabetes mellitus: the gathering storm. They were instructed to fill up the time of drug administration and the number of capsules taken in the subject diary. 2008;56(5 Suppl):718. 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]. The implications of this result are that the subjects, who were initially classified as obese, can now be defined as overweight as their mean BMI fell below 30kg/m2. International Association for the Study of Obesity. In order to investigate the effect of chitosan at a daily dose of 2.5g, we conducted a randomised, placebo-controlled clinical trial to evaluate the safety and efficacy of KiOnutrime-CsG capsules (Chitosan, 500mg) in treatment of excess weight in the absence of dietary modifications. Nutr J. Health-related quality of life in a randomised placebo-controlled trial of sibutramine in obese patients with type II diabetes. However, within placebo group there was statistically significant reduction (p=0.0334) observed at day 45 only as compared to its baseline values, while at day 90 it again increased and was statistically non-significant (p=0.8269) as compared to its baseline values (Table5). Only about 6.8% (n=4) subjects at day 45 and 7.1% (n=4) subjects at day 90 were non-responders in chitosan group, while in placebo group, the percentage of non-responders were 45.2% (n=14) and 46.7% (n=14) subjects at day 45 and day 90, respectively. The author(s) declare that they have no competing interests. Study participants also completed a SF-36 (Short Form 36) health-related quality of life (QoL) questionnaire [27, 28] at each visit except the randomisation visit.