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P values of less than 0.05 were considered as statistically significant difference between and within treatment groups. In chitosan group, body weight was reduced from 80.1311.47kg at baseline to 77.7511.56 at day 45 and 76.8911.88kg at the end of 90days, which was statistically significant (p<0.0001) when compared with baseline measurements. 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. Expert Opin Pharmacother. They were instructed not to change their routine dietary habits. 1994;58(9):161720. Table3 describes the absolute values of each study parameters at baseline, at day 45 and day 90 and Table4 describes the change in each parameter at day 45 and day 90 from baseline. Acta Toxicologica et Therapeutica. Rizzo M, Perez-Martinez P, Nikolic D, Montalto G, Lopez-Miranda J. J Mater Sci Mater Med. Lipid levels were unaffected and all adverse events were mild in nature and unrelated to study treatment. Schiller RN, Barrager E, Schauss AG, Nichols EJ. 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. A total of 86 subjects completed the study. 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). VM participated in design of the study, and revising and finalizing the manuscript.

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]. 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 significant was the percentage of subjects who lost between 5 and 10% of body weight after 90days compared to placebo group (32.4 and 3.3%, respectively). It is typically recommended that chitosan supplements be ingested approximately 15min to 1h prior to a meal in order to allow sufficient time for chitosan to dissolve in the stomach acid[18]. In placebo group, however, visceral fat remained unchanged at day 45 (10.552.75%) and at the end of 90days (10.432.87%). PHZ participated as investigator in the study, involved in subject recruitment, their compliance and acquisition of the data. It is already reported that chitosan can regulate lipids with benefit on anthropometric parameters [37]. 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. 1993;17(3):S412. However, there was no significant difference between treatments (p=0.581, 0.798, 0.969 at day 0, 45 and 90 respectively). KiOnutrime-CsG is an alternative to crustacean-derived chitosan. Ni Mhurchu C, Bennett D, Lin R, Hackett M, Jull A, Rodgers A. Obesity and health-related quality of life: results from a weight loss trial. Am J Clin Nutr. This study demonstrates that administration of chitosan (KiOnutrime-CsG capsules, 500mg, 5 capsules/day in three divided doses) results in a significant mean weight loss of about 3kg without diet restriction over a period of 90days. ORahilly S. Science, medicine, and the future. A phase IV, randomised, multicentre, single-blind, placebo-controlled, clinical study was conducted by administering chitosan capsules (500mg, five/day) and indistinguishable placebo capsules as daily supplements to 96 overweight and obese subjects for 90days. One of the most efficient and safe method would be a reduction in fat intake, as obesity is directly associated with total fat consumption [9]. There are several approaches through which pharmacotherapies are directed to treat obesity. Minerva Cardioangiol. In summary, we conclude that KiOnutrime-CsG capsule, containing 500mg of chitosan from fungal origin, was able to reduce the mean body weight up to 3kg during the 90-days study period. 2015;26(3):135. doi: 110.1007/s10856-10015-15461-z. 1993;306(6890):143740. 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. Chitin. Change in SF-36 QoL scale from baseline was also assessed to evaluate safety and efficacy of KiOnutrime-CsG capsules. The PCS score reflected physical morbidity and adaptation to disease, whereas the MCS score referred to mental morbidity and adaptation. Treatment of obesity includes lifestyle-based intervention (diet, exercise, and behaviour therapy) and medical or surgical intervention (pharmacotherapy or bariatric surgery). 2004;28(4):6005. Subjects were instructed to take one capsule in the morning, 2 capsules 15min before lunch and 2 capsules 15min before dinner with a glass of water. 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. The effects of weight loss treatments on upper and lower body fat.

The primary objective of the present study was to evaluate the efficacy and safety of a chitosan from fungal origin in treatment of excess weight in the absence of dietary restrictions. Food Funct. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. 1. Obesity. Kerch G. The Potential of Chitosan and Its Derivatives in Prevention and Treatment of Age-Related Diseases. Chitin Enzymology. The chitosan used in the study was chitosan derived from Aspergillus niger. All authors have read and approved the final manuscript. Sciutto AM, Colombo P. Lipid-lowering effect of chitosan dietary integrator and hypocaloric diet in obese subjects. 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. All analyses were completed within 12h of blood collection and all methods were validated by three freeze-thaw cycles. 1993;57(9):143944. 2004;117(1207):U1211. Similarly, body fat was significantly reduced (p<0.0001) in subjects administered with chitosan at the end of 90days (37.886.86, 37.367.03 and 36.657.25 at baseline, day 45 and day 90 respectively) (Table3), while it was increased slightly in placebo group (p=0.5684). Int J Obes Relat Metab Disord. We are thankful to all the subjects who gave their consent to participate in this trial, without which this work was not possible. Single-blind, placebo controlled randomised clinical study of chitosan for body weight reduction. 2004;3:3. 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. Halloran LG, Schwartz CC, Vlahcevic ZR, Nisman RM, Swell L. Evidence for high-density lipoprotein-free cholesterol as the primary precursor for bile-acid synthesis in man. Manage cookies/Do not sell my data we use in the preference centre. Anthropometric determinations were made using non-stretch measuring tape to the nearest 0.1cm. Sjostrom L, Narbro K, Sjostrom D. Costs and benefits when treating obesity. Springer Nature. However, more clinical studies are required to confirm this effect of chitosan in large diabetic population. 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. 1998;67(1):449. Daniels SR, Arnett DK, Eckel RH, Gidding SS, Hayman LL, Kumanyika S, et al. Ho SC, Tai ES, Eng PH, Tan CE, Fok AC. In the absence of dietary surveillance, chitosan does not reduce plasma lipids or obesity in hypercholesterolaemic obese Asian subjects. VR Trivedi. Jenkinson C, Coulter A, Wright L. Short form 36 (SF36) health survey questionnaire: normative data for adults of working age. Pokhis K, Bitterlich N, Cornelli U, Cassano G. Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation. Boston, MA: The Health Institute, New England Medical Centre; 1994. 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]. 2001;3(6):40510. 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. 2008;56(5 Suppl):718. Safety was assessed by evaluating safety parameters and monitoring adverse events. 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). 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.

CAS This was assessed by an independent dietician. JVT participated as investigator in the study, involved in subject recruitment, their compliance and acquisition of the data. Kopelman PG. The observed weight loss in chitosan group is in contrast to only 0.3kg weight loss in placebo group. 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. No dropout was observed due to AEs, which states that overall the study treatment was safe and well tolerated by all study subjects. Reduction in the mean body weight over a period of 45 and 90days intervention for chitosan and placebo group was assessed. VRT participated in analyses and interpretation of data, performed the statistical analyses, and writing, revising, and finalizing the manuscript. Terms and Conditions, 1980;33(4):78793. The sample size of this study was based on the primary objective of reduction in the body weight after 90days treatment with chitosan. 2005;111(15):19992012. Changes in measurements of body fat distribution accompanying weight change. doi: 510.1177/0003319713493126. Jo SH, Ha KS, Moon KS, Kim JG, Oh CG, Kim YC, et al. Rizzo M, Giglio RV, Nikolic D, Patti AM, Campanella C, Cocchi M, et al. 2014;20(40):624955. The primary efficacy end point was reduction in body weight in kilograms on day 45 and day 90 compared to baseline. This was thawed and allowed to come to room temperature just before the estimation of HbA1c by immunoturbidimetry assay (Bio-Rad Laboratories, India; Model D-10), lipid parameters by direct enzymatic colorimetric assay and biochemistry determinations (SGPT and SGOT by IFCC method; urea by urease kinetic method; creatinine by buffered Jaffes method) (Roche Diagnostic Limited, Switzerland; Model Cobas Integra 400 plus). Am J Epidemiol. Nutr J. 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. There are number of reports which demonstrate that chitosan binds dietary lipids and bile acids in in-vitro, pre-clinical and human studies [1519]. 1989;119(8):11006. Part of Evaluating efficacy of a chitosan product using a double-blinded, placebo-controlled protocol. Am J Clin Nutr. 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]. Edited by A.A.Muzzarelli R: Atec Edizioni, Grottammare; 2000: 6576. 1978;84(1):17. MCS participated in design of the study, analyses and interpretation of data, performed the statistical analyses, and revising and finalizing the manuscript. 1978;31(5):76973. There was no significant difference between the baseline demographics of study participants in each treatment group (Table1). The reduction in body weight caused a comparable decrease in anthropometric measurement as well. Safety was evaluated by clinically and physically observing and reporting adverse events (AE) and assessing changes in vital signs, and biochemistry parameters. Anthropometric indexes such as the body mass index (BMI) and waist-to-hip ratio (WHR) remain the most commonly used tools for assessing body composition because of their simplicity and low cost [3]. 1995;19(6):S9S12. Caan B, Armstrong MA, Selby JV, Sadler M, Folsom AR, Jacobs D, et al. Google Scholar. Kanauchi O, Deuchi K, Imasato Y, Kobayashi E. Increasing Effect of a Chitosan and Ascorbic Acid Mixture on Fecal Dietary Fat Excretion. Epub 0003319713492013 Jun 0003319713493118. PubMedGoogle Scholar. Ventura P. Lipid lowering activity of chitosan, a new dietary integrator. Among the reasons for these variable outcomes are inadequate dosage of chitosan and/or variation of caloric intake throughout the study (changes in food habits/inconsistent diet). Globally, IASO/IOTF also estimated that up to 10% (~200 million) school aged children were either overweight or obese, 20% of which are in European Union [4]. 1995;16(4):199214. J Am Nutraceut Assoc. 2013;14(7):1421424. International Association for the Study of Obesity. Int J Obes Relat Metab Disord. 1999;53(5):37981. Astrup A. Dietary composition, substrate balances and body fat in subjects with a predisposition to obesity.

Maezaki Y, Tsuji K, Nakagawa Y, Kawai Y, Akimoto M, Tsugita T, et al. Acta Toxicol Ther. 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. HbA1c level at baseline was compared with post-administration measurements at day 45 and day 90 to assess the efficacy of chitosancapsules. Br Heart J. Singapore Med J. 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. Circulation. They were instructed to fill up the time of drug administration and the number of capsules taken in the subject diary. A novel use of chitosan as a hypocholesterolemic agent in rats. 2022 BioMed Central Ltd unless otherwise stated. Epub 12015 Feb 10826. Biosci Biotechnol Biochem. Chitosan is a dietary fibre which acts by reducing fat absorption and thus used as a means for controlling weight. 2007;6:31. CAS Considering dropout rate of 20%, adjusted sample size will be 90 (60 subjects in KiOnutrime-CsG group and 30 subjects in placebo group after considering randomization ratio of 2:1). Chitosan is a popular dietary fibre often used to prevent dietary fat absorption as a means for controlling weight. 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]. While in the placebo group, the percentage of subjects who reduced body weight in the same range was 41.9% (n=13), 12.9% (n=4) and 0% (n=0) at day 45 and 40.0% (n=12), 10.0% (n=3) and 3.3% (n=1) at the end of day 90, respectively. Mar Drugs. These include, limiting the absorption of food, suppressing appetite and reducing food intake, and altering metabolism or increasing energy expenditure [5]. It is noteworthy that in chitosan group, the percentage of subjects who reduced body weight in the range of up to 2kg, 24kg and >4kg was 54.2% (n=32), 28.8% (n=17) and 10.2% (n=6) at the end of day 45 and 10.7% (n=6), 48.2% (n=27) and 33.9% (n=19) at the end of day 90, respectively. 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. While the same for placebo group was 1761kcal, 1701kcal and 1677kcal, respectively. Brenot F, Herve P, Petitpretz P, Parent F, Duroux P, Simonneau G. Primary pulmonary hypertension and fenfluramine use.

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. 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. All study participants provided voluntary written informed consent before initiating the screening procedures. 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]. However, mean MCS score failed to improve with the treatment. 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]. Results from the Third National Health and Nutrition Examination Survey. Physical examinations and vital signs (radial pulse, blood pressure, respiratory rate, and body temperature) were carried out at all visits. Lipids Health Dis. Additionally, there was also improvement in QoL score. The author(s) declare that they have no competing interests. Newer classifications of obesity are based on simple measures such as waist hip ratio, total adiposity and intra-abdominal fatness. 2014;5(10):26629. Eur J Clin Nutr. 2004;28(9):114956. Nutrition Journal Each bottle of study medication contained 75 capsules for total 15days administration. Obesity: an overview on its current perspectives and treatment options. The average calorie intake for the period of day 15, day 4145 and day 8690 was calculated for both the groups. Assessment of daily average calorie intake was also carried out by recording the subjects diet from their food diary to confirm whether there wasany influence of diet on the observed weight loss. The binding of micellar lipids to chitosan. The effects of chitosan as a treatment for overweight and obesity has been evaluated in many clinical trials of great variability in terms of study design and quality resulting to somewhere inconsistent results [2025]. Ebihara K, Schneeman BO. This may the reason for the observed decrease in HbA1c levels in our study. Health-related quality of life in a randomised placebo-controlled trial of sibutramine in obese patients with type II diabetes. The effects of chitosan oligosaccharide (GO2KA1) supplementation on glucose control in subjects with prediabetes. California Privacy Statement, Angiology. Patti AM, Katsiki N, Nikolic D, Al-Rasadi K, Rizzo M. Nutraceuticals in Lipid-Lowering Treatment: A Narrative Review on the Role of Chitosan. Cite this article. Effects of chitosan on plasma lipids and lipoproteins: a 4-month prospective pilot study. Subjects visited the study centre four times for evaluation of study parameters: during screening (Visit 1; Day -5 to 0), enrolment/randomisation visit (Visit 2; Day 1), follow-up visit (Visit 3; Day 452) and end of study visit (Visit 4; Day 903). Of these, 64 subjects were randomly assigned to the chitosan group and 32 to the placebo group.

2013;14(14):186973. One factor which is important to consider is the timing of chitosan ingestion before meals. The study participants were divided in 2:1 ratio to receive either chitosan (n=64) or placebo (n=32). Article BMI correlates fairly well with total body fat on a population basis [32]. BMJ. In chitosan group, the mean change in body weight was -1.781.37kg (range: -5.30 to 0.80kg) and -3.101.95kg (range: -9.00 to 1.90kg) at day 45 and day 90, respectively. Kaukua JK, Pekkarinen TA, Rissanen AM. The mean changes in body weight were -1.781.37kg and -3.101.95kg at day 45 and day 90 respectively in chitosan group which were significantly different (p<0.0001) as compared to placebo. Single-blind, placebo controlled randomised clinical study of chitosan for body weight reduction, https://doi.org/10.1186/s12937-016-0122-8, http://www.worldobesity.org/site_media/uploads/IASO-Advocacy-toolkit-Oct13.pdf, http://creativecommons.org/licenses/by/4.0/, http://creativecommons.org/publicdomain/zero/1.0/. Figure1 describes the disposition of the study subjects. Isolation of chitosan from Ganoderma lucidum mushroom for biomedical applications.