chitosan weight loss study

2021/05/21

Nutr J. The sample size of this study was based on the primary objective of reduction in the body weight after 90days treatment with chitosan.

Cite this article. Chitosan is a dietary fibre which acts by reducing fat absorption and thus used 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). KiOnutrime-CsG is an alternative to crustacean-derived chitosan. Pittler MH, Abbot NC, Harkness EF, Ernst E. Randomized, double-blind trial of chitosan for body weight reduction. However, there was no statistical difference between both treatments at any time points. Lipid levels in both treatment groups are described in Table5. Maezaki Y, Tsuji K, Nakagawa Y, Kawai Y, Akimoto M, Tsugita T, et al. Curr Pharm Des. The observed weight loss in chitosan group is in contrast to only 0.3kg weight loss in placebo group. Deibert P, Konig D, Vitolins MZ, Landmann U, Frey I, Zahradnik HP, et al. 1978;84(1):17. California Privacy Statement, Patti AM, Katsiki N, Nikolic D, Al-Rasadi K, Rizzo M. Nutraceuticals in Lipid-Lowering Treatment: A Narrative Review on the Role of Chitosan. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Changes in measurements of body fat distribution accompanying weight change. Effect of a new chitosan dietary integrator and hypocaloric diet on hyperlipidemia and overweight in obese patients. Acta Toxicol Ther. Am J Clin Nutr. Caan B, Armstrong MA, Selby JV, Sadler M, Folsom AR, Jacobs D, et al.

Each bottle of study medication contained 75 capsules for total 15days administration. dietary evidence batsis 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]. It is established that inflammation, diabetes and obesity are interrelated and a person with diabetes are predisposed to obesity and metabolic syndrome. 1998;67(1):449. Audio-video recording of the entire informed consent process was carried out according to the schedule Y of Indian GCP.Out of the 102 screened subjects, 96 subjects were enrolled in the study. 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. 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. 1996;2:5562. N Z Med J. Additionally, there was also improvement in QoL score. 1999;53(5):37981. 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. Baseline demographic characteristics (meanSD) for subjects in the chitosan group were, age 35.53 ( 11.23) years; weight and height 80.13 ( 11.47) kg and 1.61 ( 0.10) m, respectively and for the placebo group were, age 36.28 ( 10.49) years; weight and height 80.54 ( 12.68) kg and 1.61 ( 0.09) m,respectively. All study participants provided voluntary written informed consent before initiating the screening procedures. 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). 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]. A total of 15 subjects in chitosan group and 6 subjects in placebo group had hypertension, diabetes mellitus, dyslipidemia or their combination. Additionally, there was also improvement in QoL score. Angiology. Nauss JL, Thompson JL, Nagyvary J. HbA1C reflects the long-term glycaemic level and is a marker for progression of diabetes. This can also be observed by reduction of muscle mass in the range of -11.50 to +1.20 in chitosan group as compared to -3.20 to +3.10 in placebo group at day 90 (Table4). Kanauchi O, Deuchi K, Imasato Y, Kobayashi E. Increasing Effect of a Chitosan and Ascorbic Acid Mixture on Fecal Dietary Fat Excretion. Effect of a weight loss intervention on anthropometric measures and metabolic risk factors in pre- versus postmenopausal women. Cookies policy. A total of 86 subjects completed the study. Effects of chitosan on plasma lipids and lipoproteins: a 4-month prospective pilot study. 2015;2(25):0150053. While in placebo group the body weight was 80.5412.68kg at baseline, which minimally changed to 80.8912.15kg at 45days and 80.7612.31kg at the end of 90days of treatment, which was statistically non-significant. Manage cookies/Do not sell my data we use in the preference centre. statement and Together with this, there was also improvement in body composition, anthropometric parameters and HbA1C, reflecting overall benefits for the overweight individuals. This further decreased to 9.713.33% at the end of 90days administration (Table3). 1993;57(9):143944. The study protocol and protocol-related documents were approved by the institutional ethics committee of each site before initiating any trial related activity. Obesity: an overview on its current perspectives and treatment options. Am J Epidemiol. International Association for the Study of Obesity (IASO), and the International Obesity Task Force (IOTF) estimated, in a study jointly conducted in 2010, that approximately 1.5 billion adults were overweight with around 475 million obese adults. They were instructed not to change their routine dietary habits. BMC Obes. All the statistical analyses were carried out using SAS v9.0 (SAS Institute Inc, Cary, NC, USA). 1989;119(8):11006. Lipids Health Dis. Rizzo M, Perez-Martinez P, Nikolic D, Montalto G, Lopez-Miranda J. 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. In placebo group, however, visceral fat remained unchanged at day 45 (10.552.75%) and at the end of 90days (10.432.87%). For preliminary phase screening, a total of 177 study participants either included in hospitals databases or under doctors referral were initially contacted. BMJ. In: Chitosan per os - from dietary supplement to drug carrier. 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]. In our study, the dosage was one capsule 15min before breakfast and two capsules each 15min before lunch and dinner. Pokhis K, Bitterlich N, Cornelli U, Cassano G. Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation. Int J Mol Sci. 2004;28(9):114956. The mean PCS score and mean MCS score obtained in placebo group at day 0 were 41.265.78 and 46.167.77, respectively and at day 90 were 43.197.50 and 47.456.60, respectively.Assessment of Quality of Life (QoL) using SF-36 questionnaire showed statistical significant (p<0.0001) increase in QoL score in subjects from chitosan group as compared to the placebo group from baseline to day 90, which depicts improvement in the QoL (Table6). This may the reason for the observed decrease in HbA1c levels in our study.

The effect of the dietary supplement, Chitosan, on body weight: a randomised controlled trial in 250 overweight and obese adults. 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]. Change in SF-36 QoL scale from baseline was also assessed to evaluate safety and efficacy of KiOnutrime-CsG capsules. 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). But when mean changes in reduction of visceral fat from baseline was compared (Table4), it was observed that chitosan showed significantly higher (p<0.001) reduction in visceral fat as compared to placebo on day 90 (1.281.12% vs 0.430.85). 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 90. 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. These results were significantly different (p<0.0001) as compared to placebo where mean change in body weight was -0.311.30kg (range: -3.00 to 2.50kg) and -0.331.51kg (range: -4.60 to 2.80kg), respectively (Fig. 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]. Each enrolled subjects received Subject Information Sheet and Subject diary containing details of food consumption and drug compliance. 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). Emerging approaches for the treatment of hypertriglyceridemia. 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/. 2015;13(4):2158. Acta Toxicologica et Therapeutica. 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. CAS

2004;117(1207):U1211. 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]. Ware JE, Kosinski M, Kellar SD. Am J Clin Nutr. 2006;25(5):38994. 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. Lipid levels were unaffected and all adverse events were mild in nature and unrelated to study treatment.

AD participated in design of the study, and revising and finalizing the manuscript. No dropout was observed due to AEs, which states that overall the study treatment was safe and well tolerated by all study subjects.

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. 2015;26(3):135. doi: 110.1007/s10856-10015-15461-z. 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. Minerva Cardioangiol. The chitosan used in the study was chitosan derived from Aspergillus niger. Newer classifications of obesity are based on simple measures such as waist hip ratio, total adiposity and intra-abdominal fatness. Results were expressed as meanstandard deviation (SD). Visceral fat significantly decreased (p<0.0001) in subjects administered with chitosan at day 45 (10.473.38%) from baseline (10.803.52). KiOnutrime-CsG capsulewas also found to be safe and well tolerated by all study participants. Abelin J, Lassus A. L-112 Biopolymer - Fat binder as a weight reducer in patients with moderate obesity. These include, limiting the absorption of food, suppressing appetite and reducing food intake, and altering metabolism or increasing energy expenditure [5]. Medication compliance was considered reached when there was 90% capsules intake over a period of 90days capsules administration. PHZ participated as investigator in the study, involved in subject recruitment, their compliance and acquisition of the data. 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]. After 90days of administration, there was a further reduction in BMI in chitosan group which was in the range of -3.65 to +0.73 (mean -1.20) as compared to -1.81 to +1.14 (mean -0.11) in placebo group. 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. 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). Singapore Med J. Sciutto AM, Colombo P. Lipid-lowering effect of chitosan dietary integrator and hypocaloric diet in obese subjects. Obesity is a prevalent health hazard in developed and developing countries and is closely associated with various pathological disorders, including diabetes, hypertension, and cardiovascular diseases [1]. Shivranjani Cross Roads, Satellite, Ahmedabad, 380015, India, SAL Hospital, Drive-in Road, Ahmedabad, 380054, India, You can also search for this author in

Correspondence to Kopelman PG. 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). Provided by the Springer Nature SharedIt content-sharing initiative. Mean BMI decreased significantly (p<0.0001) over the period of 90days in chitosan group (30.932.69 at baseline to 30.202.90 at day 45 and 29.713.07 at day 90), while in placebo group it was decreased minimally but was not significant (p=0.3846) as compared to baseline values (30.912.72 at baseline to 30.952.62 at day 45 and 30.832.64 at day 90) (Table3). RBS participated as investigator in the study, involved in subject recruitment, their compliance and acquisition of the data.

We are thankful to all the subjects who gave their consent to participate in this trial, without which this work was not possible. Due to its cationic nature, chitosan binds to negatively charged lipids, hence reducing their gastrointestinal uptake and also potentially lowering serum cholesterol [14]. Int J Obes Relat Metab Disord. 1995;16(4):199214. All analyses were completed within 12h of blood collection and all methods were validated by three freeze-thaw cycles. 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. The reduction in body weight caused a comparable decrease in anthropometric measurement as well. The study medications were dispensed in pre-labelled identical bottles to all sites according to individual site randomisation schedule generated using a computerised random number generator with mixed block sizes to prevent the identity of treatment assignment. Mean changes in body fat reduction from baseline in chitosan group as compared to placebo group at day 45 (-0.381.17% vs-0.111.12%) and day 90 (-0.981.27% vs-0.050.98%) were significantly different (Table4). 2nd ed. Daniels S. Pharmacological treatment of obesity in paediatric patients. 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]. Boston, MA: The Health Institute, New England Medical Centre; 1994. 1. 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. 2014;20(40):624955. In this study we found that after 90day administration with chitosan, there was 10.91 fold reduction in BMI compared to placebo group. Safety was assessed by evaluating safety parameters and monitoring adverse events. Anthropometric determinations were made using non-stretch measuring tape to the nearest 0.1cm. Of the 102 subjects screened, a total of 96 subjects were enrolled in the study. Evaluating efficacy of a chitosan product using a double-blinded, placebo-controlled protocol. 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. International Association for the Study of Obesity. 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. 2).Table2 shows the comparison between body weights in both the groups.

Ho SC, Tai ES, Eng PH, Tan CE, Fok AC. Springer Nature. 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.

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. Health-related quality of life in a randomised placebo-controlled trial of sibutramine in obese patients with type II diabetes. There were a total of 10 adverse events (AEs) recorded during the study period: four in placebo group and six in chitosan group.

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. However, there was no significant difference between treatments (p=0.581, 0.798, 0.969 at day 0, 45 and 90 respectively). Together with this, there was also improvement in body composition, anthropometric parameters and HbA1C, reflecting overall benefits for the overweight individuals. 1993;306(6890):143740. ORahilly S. Science, medicine, and the future. 2004;28(4):6005. There are several approaches through which pharmacotherapies are directed to treat obesity. There was no stratification by sex or other demographic variables.The randomisation codes were kept in an individually sealed, opaque envelope and broken only after the completion of data lock procedures. Article Although there is a statistically significant reduction, this has not produced any clinically relevant adverse effects over a period of 90days. 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. Taylor RW, Keil D, Gold EJ, Williams SM, Goulding A. Int J Obes Relat Metab Disord. BMJ. Again, when compared between treatments, the values were statistically non-significant. Each capsule of KiOnutrime-CsG contained 500mg chitosan with excipients (magnesium stearate and colloidal silicone dioxide). LDL and HDL subfractions, dysfunctional HDL: treatment options. Acta Toxicol Ther. Brenot F, Herve P, Petitpretz P, Parent F, Duroux P, Simonneau G. Primary pulmonary hypertension and fenfluramine use. Chitin Enzymology. Ebihara K, Schneeman BO. 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. 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. Int J Obes Relat Metab Disord. In this study, HbA1c level was significantly decreased at day 45 (5.720.78%) and day 90 (5.740.83%) in chitosan group as compared to its baseline value (5.890.83), which was statistically significant (p=0.0327). Serum samples were separated (4000rpm, 15min, 4C), immediately frozen and stored at -20 C until analysed. The primary efficacy end point was reduction in body weight in kilograms on day 45 and day 90 compared to baseline. 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. Cornelli U, Belcaro G, Cesarone MR, Cornelli M. Use of polyglucosamine and physical activity to reduce body weight and dyslipidemia in moderately overweight subjects. 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 the absence of dietary surveillance, chitosan does not reduce plasma lipids or obesity in hypercholesterolaemic obese Asian subjects. 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). 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]. Astrup A. Dietary composition, substrate balances and body fat in subjects with a predisposition to obesity. Results from the Third National Health and Nutrition Examination Survey. BMI was decreased by10.91 fold compared to placebo after 90day administration. Google Scholar. HbA1c level at baseline was compared with post-administration measurements at day 45 and day 90 to assess the efficacy of chitosancapsules. Veneroni G, Veneroni F, Contos S, Tripodi S, De Bernardi M, Guarino C, et al. SF-36 physical and mental health summary scales: a users manual. 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. Onyike CU, Crum RM, Lee HB, Lyketsos CG, Eaton WW.