VM participated in design of the study, and revising and finalizing the manuscript. 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. 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%). 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. 2001;3(6):40510. Epub 12015 Feb 10826. The questionnaire consisted of eight multi-item dimensions. dietary evidence batsis All study participants provided voluntary written informed consent before initiating the screening procedures. American College of Cardiology/American Heart Association Task Force on Practice Guidelines, Obesity Expert Panel. Epub 0003319713492013 Jun 0003319713493118. 2012;11(122):11122. Visceral fat significantly decreased (p<0.0001) in subjects administered with chitosan at day 45 (10.473.38%) from baseline (10.803.52). 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]. Paediatr Drugs. Weight loss clinical trial outcomes, however, have contradictory results regarding its efficacy.
Privacy Food Funct. 2015;26(3):135. doi: 110.1007/s10856-10015-15461-z. 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. 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. Google Scholar, About Obesity [http://www.worldobesity.org/site_media/uploads/IASO-Advocacy-toolkit-Oct13.pdf]. They were instructed to fill up the time of drug administration and the number of capsules taken in the subject diary. The mean caloric intake in chitosan group for day 15 was 1784kcal, for day 4145 was 1797kcal and for day 8690 was 1750kcal. 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. Garcia-Rios A, Nikolic D, Perez-Martinez P, Lopez-Miranda J, Rizzo M, Hoogeveen RC. Changes in measurements of body fat distribution accompanying weight change. This was assessed by an independent dietician. 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. Kaukua JK, Pekkarinen TA, Rissanen AM. BMJ. Single-blind, placebo controlled randomised clinical study of chitosan for body weight reduction. There were a total of 10 adverse events (AEs) recorded during the study period: four in placebo group and six in chitosan group. 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. Manage cookies/Do not sell my data we use in the preference centre. 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. 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]. Google Scholar. The chitosan used in the study was chitosan derived from Aspergillus niger. Springer Nature. The effects of weight loss treatments on upper and lower body fat. Together with this, there was also improvement in body composition, anthropometric parameters and HbA1C, reflecting overall benefits for the overweight individuals.
Kerch G. The Potential of Chitosan and Its Derivatives in Prevention and Treatment of Age-Related Diseases. 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). 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].
Emerging approaches for the treatment of hypertriglyceridemia. Epub 02014 Sep 00415. Biosci Biotechnol Biochem. 2015;2(25):0150053. 1995;16(4):199214. 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].
Also, hypocholesterolemic properties of chitosan decrease the risk of atherosclerosis and other cardiovascular dysfunctions [36]. 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]. Results were expressed as meanstandard deviation (SD). chitosan scaffold polyhydroxybutyrate bioglass characterization electrospun nanocomposite scaffolds absorption One factor which is important to consider is the timing of chitosan ingestion before meals. 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). Nutr J. Caan B, Armstrong MA, Selby JV, Sadler M, Folsom AR, Jacobs D, et al. Newer classifications of obesity are based on simple measures such as waist hip ratio, total adiposity and intra-abdominal fatness. Nauss JL, Thompson JL, Nagyvary J. 2015;13(4):2158. Surgery. doi: 2610.1039/c2664fo00469h. Cite this article. 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. Helsinki: Medical research report performed at ARS Medicina; 1994. The effect of the dietary supplement, Chitosan, on body weight: a randomised controlled trial in 250 overweight and obese adults. In our study, the dosage was one capsule 15min before breakfast and two capsules each 15min before lunch and dinner. 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. Nammi S, Koka S, Chinnala KM, Boini KM. 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). 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/. 2).Table2 shows the comparison between body weights in both the groups. 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). PubMedGoogle Scholar. Article Daniels SR, Arnett DK, Eckel RH, Gidding SS, Hayman LL, Kumanyika S, et al. 2001;4:429. Wadstein J, Thom E, Heldman E, Gudmunsson S, Lilja B: Biopolymer L112, a chitosan with fat binding properties and potential as a weight reducing agent: a review of in vitro and in vivo experiments. 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]. Daniels S. Pharmacological treatment of obesity in paediatric patients. 1995;19(6):S9S12. International Association for the Study of Obesity. 2015;66(5):41621. J Mater Sci Mater Med. 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. 2008;56(5 Suppl):718. 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. 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]. 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. Nutr J. browning chinese fresh cut compounds effects anti different eleocharis tuberosa chestnut structure study properties decay water
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. 1989;119(8):11006. We are thankful to all the subjects who gave their consent to participate in this trial, without which this work was not possible. Google Scholar. It is a cationic polysaccharide produced by deacetylation (hydrolysis of the N-acetyl-D-glucosamine units) of the biopolymer chitin, which is derived from the cuticles of crustaceans such as shrimp, crab, and lobster [10], or from the cell wall of mushroom [11]. Overweight in children and adolescents: pathophysiology, consequences, prevention, and treatment. The effects of chitosan oligosaccharide (GO2KA1) supplementation on glucose control in subjects with prediabetes. Schiller RN, Barrager E, Schauss AG, Nichols EJ. Lipid levels in both treatment groups are described in Table5. Serum samples were separated (4000rpm, 15min, 4C), immediately frozen and stored at -20 C until analysed. Mhurchu CN, Poppitt SD, McGill AT, Leahy FE, Bennett DA, Lin RB, et al. 2022 BioMed Central Ltd unless otherwise stated. Of the 102 subjects screened, a total of 96 subjects were enrolled in the study. Minerva Cardioangiol. 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). 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. Body weight gain and increase in BMI are the key clinical features of obesity. P values of less than 0.05 were considered as statistically significant difference between and within treatment groups. Mar Drugs. Although there is a statistically significant reduction, this has not produced any clinically relevant adverse effects over a period of 90days. 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. https://doi.org/10.1186/s12937-016-0122-8, DOI: https://doi.org/10.1186/s12937-016-0122-8. This further decreased to 9.713.33% at the end of 90days administration (Table3). 1995;16(4):21530. 1998;67(1):449. Boston, MA: The Health Institute, New England Medical Centre; 1994. 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]. There was no significant difference between the baseline demographics of study participants in each treatment group (Table1). Chitin Enzymology. Nutr J 15, 3 (2015). Edited by A.A.Muzzarelli R: Atec Edizioni, Grottammare; 2000: 6576. In placebo group, however, visceral fat remained unchanged at day 45 (10.552.75%) and at the end of 90days (10.432.87%). Int J Obes Relat Metab Disord. While the same for placebo group was 1761kcal, 1701kcal and 1677kcal, respectively. Am J Clin Nutr. This may the reason for the observed decrease in HbA1c levels in our study. The binding of micellar lipids to chitosan. Subjects were also advised to maintain their normal routine diet and to record the type and amount of food consumed (for periods of 5days between days 15, days 4145 and days 8690) in the food diary provided, to calculate and analyse the daily caloric value. 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. Efficacy was assessed by measuring body weight, body composition parameters, anthropometric measurements, HbA1C level and lipid profile at day 45 and day 90. 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. Acta Toxicologica et Therapeutica. Additionally, there was also improvement in QoL score. 2013;14(7):1421424. 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]. 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. 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). Results from the Third National Health and Nutrition Examination Survey. However, there was no statistical difference between both treatments at any time points. 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]. Out of this, 102 subjects were selected for screening and 75 subjects were not selected based on the reasons described in Fig. Provided by the Springer Nature SharedIt content-sharing initiative. Effect of a weight loss intervention on anthropometric measures and metabolic risk factors in pre- versus postmenopausal women. VRT participated in analyses and interpretation of data, performed the statistical analyses, and writing, revising, and finalizing the manuscript. It is established that inflammation, diabetes and obesity are interrelated and a person with diabetes are predisposed to obesity and metabolic syndrome.
By using this website, you agree to our Physical examinations and vital signs (radial pulse, blood pressure, respiratory rate, and body temperature) were carried out at all visits. Abelin J, Lassus A. L-112 Biopolymer - Fat binder as a weight reducer in patients with moderate obesity. sliminazer revita pharm
1980;33(4):78793. 2014;5(10):26629. 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. Sjostrom L, Narbro K, Sjostrom D. Costs and benefits when treating obesity. There are number of reports which demonstrate that chitosan binds dietary lipids and bile acids in in-vitro, pre-clinical and human studies [1519]. HbA1c level at baseline was compared with post-administration measurements at day 45 and day 90 to assess the efficacy of chitosancapsules.
1994;58(9):161720.
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). Shivranjani Cross Roads, Satellite, Ahmedabad, 380015, India, SAL Hospital, Drive-in Road, Ahmedabad, 380054, India, You can also search for this author in Safety was assessed by evaluating safety parameters and monitoring adverse events.
Reduction in the mean body weight over a period of 45 and 90days intervention for chitosan and placebo group was assessed. hydrogel dispersion retention degradation eimear galway biomedical 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. It was safe and well tolerated by all subjects. 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;65(6):53842. Lipids Health Dis. 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). Deibert P, Konig D, Vitolins MZ, Landmann U, Frey I, Zahradnik HP, et al. Article
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. 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. 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. Obesity: an overview on its current perspectives and treatment options. SF-36 physical and mental health summary scales: a users manual. RBS participated as investigator in the study, involved in subject recruitment, their compliance and acquisition of the data. A total of 15 subjects in chitosan group and 6 subjects in placebo group had hypertension, diabetes mellitus, dyslipidemia or their combination. 1997;314(7085):9559. Treatment of obesity includes lifestyle-based intervention (diet, exercise, and behaviour therapy) and medical or surgical intervention (pharmacotherapy or bariatric surgery). 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. 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. Am J Epidemiol. Chitosan is a popular dietary fibre often used to prevent dietary fat absorption as a means for controlling weight. 1993;17(3):S412.
ORahilly S. Science, medicine, and the future. In: Chitosan per os - from dietary supplement to drug carrier. The PCS score reflected physical morbidity and adaptation to disease, whereas the MCS score referred to mental morbidity and adaptation. 1994;18(6):397404. 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. 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. 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. Muzzarelli RAA. 2014;20(40):624955. Each capsule of KiOnutrime-CsG contained 500mg chitosan with excipients (magnesium stearate and colloidal silicone dioxide). Isolation of chitosan from Ganoderma lucidum mushroom for biomedical applications. The distribution of the variables was investigated using the Kolmogorov-Smirnov test. CAS Lipids. 2004;117(1207):U1211. 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. Is obesity associated with major depression? Rizzo M, Giglio RV, Nikolic D, Patti AM, Campanella C, Cocchi M, et al. Cornelli U, Belcaro G, Cesarone MR, Cornelli M. Use of polyglucosamine and physical activity to reduce body weight and dyslipidemia in moderately overweight subjects. Int J Mol Sci. Evaluating efficacy of a chitosan product using a double-blinded, placebo-controlled protocol. Acta Toxicol Ther. Curr Pharm Des. This 2:1 ratio was decided to limit the exposure of placebo formulation to half of the subjects only. Non-insulin dependent diabetes mellitus: the gathering storm. 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). Oxford, England: Pergamon Press; 1977. All analyses were completed within 12h of blood collection and all methods were validated by three freeze-thaw cycles. In concert with this, there was also reduction in body composition and anthropometric parameters together with improvement in QoL score. Veneroni G, Veneroni F, Contos S, Tripodi S, De Bernardi M, Guarino C, et al. Astrup A. Dietary composition, substrate balances and body fat in subjects with a predisposition to obesity. KiOnutrime-CsG is an alternative to crustacean-derived chitosan. 1978;84(1):17. The data set(s) supporting the results of this article is (are) included within the article. The mean caloric intake shows that there was no change in dietary habits of subjects in both groups. They were instructed not to change their routine dietary habits. LDL and HDL subfractions, dysfunctional HDL: treatment options.