Epub 0003319713492013 Jun 0003319713493118. All analyses were completed within 12h of blood collection and all methods were validated by three freeze-thaw cycles. 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]. Biosci Biotechnol Biochem. 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. Biosci Biotechnol Biochem. Int J Obes Relat Metab Disord. 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. Am J Clin Nutr. 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]. 1994;58(9):161720. Pittler MH, Abbot NC, Harkness EF, Ernst E. Randomized, double-blind trial of chitosan for body weight reduction. 1996;2:5562. Singapore Med J. Dosage compliance was assessed counting the unused quantity of medication from returned bottles. It is already reported that chitosan can regulate lipids with benefit on anthropometric parameters [37]. 2004;3:3. Jo SH, Ha KS, Moon KS, Kim JG, Oh CG, Kim YC, et al. Acta Toxicol Ther. 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. However, there was no significant difference between treatments (p=0.581, 0.798, 0.969 at day 0, 45 and 90 respectively). All the statistical analyses were carried out using SAS v9.0 (SAS Institute Inc, Cary, NC, USA). BMC Obes. Is obesity associated with major depression? These include, limiting the absorption of food, suppressing appetite and reducing food intake, and altering metabolism or increasing energy expenditure [5]. 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. 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. 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]. 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 author(s) declare that they have no competing interests. While the same for placebo group was 1761kcal, 1701kcal and 1677kcal, respectively. 2012;11(122):11122. statement and Int J Mol Sci. 2).Table2 shows the comparison between body weights in both the groups. Eur J Clin Nutr. CAS In placebo group, however, visceral fat remained unchanged at day 45 (10.552.75%) and at the end of 90days (10.432.87%). Single-blind, placebo controlled randomised clinical study of chitosan for body weight reduction. 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. 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. Each capsule of KiOnutrime-CsG contained 500mg chitosan with excipients (magnesium stearate and colloidal silicone dioxide). Chitosan was also able to reduce HbA1C levels (below 6%) in subjects who had initial higher values. 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. 2005;111(15):19992012. 1995;16(4):199214. The observed weight loss in chitosan group is in contrast to only 0.3kg weight loss in placebo group. Acta Toxicologica et Therapeutica. The binding of micellar lipids to chitosan. Daniels SR, Arnett DK, Eckel RH, Gidding SS, Hayman LL, Kumanyika S, et al. 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. Kaukua JK, Pekkarinen TA, Rissanen AM. 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]. However, only one of the subjects in our study showed weight loss of more than 10%, thus explaining the differences in PCS and MCS score. Caan B, Armstrong MA, Selby JV, Sadler M, Folsom AR, Jacobs D, et al. 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]. 2022 BioMed Central Ltd unless otherwise stated. Ventura P. Lipid lowering activity of chitosan, a new dietary integrator. Bray GA, Greenway FL, Molitch ME, Dahms WT, Atkinson RL, Hamilton K. Use of anthropometric measures to assess weight loss. 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). The PCS score reflected physical morbidity and adaptation to disease, whereas the MCS score referred to mental morbidity and adaptation. Springer Nature. Nauss JL, Thompson JL, Nagyvary J. 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. Trivedi, V., Satia, M., Deschamps, A. et al. The study participants were divided in 2:1 ratio to receive either chitosan (n=64) or placebo (n=32). 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. Obesity: an overview on its current perspectives and treatment options. Int J Obes Relat Metab Disord. Angiology. Expert panel report: Guidelines (2013) for the management of overweight and obesity in adults. 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. In a similar previous study where effects of chitosan was studied on lipids and lipoproteins, it was found that chitosan increased HDL level up to 14% during the 4-month study period [42]. A novel use of chitosan as a hypocholesterolemic agent in rats. In simple terms, it may be defined as a state of imbalance between calories ingested versus calories expended which would lead to excessive or abnormal fat accumulation [2]. Garcia-Rios A, Nikolic D, Perez-Martinez P, Lopez-Miranda J, Rizzo M, Hoogeveen RC. 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. 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. J Am Nutraceut Assoc. Again, when compared between treatments, the values were statistically non-significant. The primary efficacy end point was reduction in body weight in kilograms on day 45 and day 90 compared to baseline. P values of less than 0.05 were considered as statistically significant difference between and within treatment groups. Veneroni G, Veneroni F, Contos S, Tripodi S, De Bernardi M, Guarino C, et al. Curr Pharm Des. Interaction of bile acids, phospholipids, cholesterol and triglyceride with dietary fibers in the small intestine of rats. 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. Safety was evaluated by clinically and physically observing and reporting adverse events (AE) and assessing changes in vital signs, and biochemistry parameters. J Mater Sci Mater Med. Ware JE, Kosinski M, Kellar SD. BMI was decreased by10.91 fold compared to placebo after 90day administration. 1996;17:5370. 1. 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. Paediatr Drugs. 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. Effect of a weight loss intervention on anthropometric measures and metabolic risk factors in pre- versus postmenopausal women. doi: 510.1177/0003319713493126. Jenkinson C, Coulter A, Wright L. Short form 36 (SF36) health survey questionnaire: normative data for adults of working age. 1997;314(7085):9559. BMI correlates fairly well with total body fat on a population basis [32]. The mean caloric intake shows that there was no change in dietary habits of subjects in both groups. PubMedGoogle Scholar. 2013;14(7):1421424. 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]. 2001;3(6):40510. 1998;67(1):449. Change in SF-36 QoL scale from baseline was also assessed to evaluate safety and efficacy of KiOnutrime-CsG capsules. 1983;18(10):7149. The data set(s) supporting the results of this article is (are) included within the article. In concert with this, there was also reduction in body composition and anthropometric parameters together with improvement in QoL score. Subjects were also instructed to visit the study centre every 15days to receive new medication containers and to assess medication compliance from the subject diary. 2nd ed. Anthropometric determinations were made using non-stretch measuring tape to the nearest 0.1cm.
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