Single-blind, placebo controlled randomised clinical study of chitosan for body weight reduction.
Background: Chitosan is a dietary fibre which acts by reducing fat absorption and thus used as a means for controlling weight. Weight loss clinical trial outcomes, however, have contradictory results regarding its efficacy. The primary objective of the present study was to evaluate the efficacy and...
| Publicado en: | Nutrition Journal pp. 3 - 4 |
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| Autores principales: | , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
BioMed Central
1/8/2016
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=112238916&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 112238916 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 14752891 1CYY jtl: Nutrition Journal issn: 14752891 maglogo: N pubinfo: dt: 1/8/2016 pid: 24147 pub: BioMed Central artinfo: ui: 112238916 112238916 1CYY20160108-00001 112238916 10.1186/s12937-016-0122-8 NLM26747458 PMC4706713 112238916 ppf: 3 ppct: 1 formats: fmt: @attributes: type: P tig: atl: Single-blind, placebo controlled randomised clinical study of chitosan for body weight reduction. aug: au: Trivedi, V. R. Satia, M. C. Deschamps, A. Maquet, V. Shah, R. B. Zinzuwadia, P. H. Trivedi, J. V. affil: Ethicare Clinical Trial Services, Titanium City Centre, 100 Feet Road, Ahmedabad, 380015 Ahmedabad, India sug: subj: Polysaccharides Administration and Dosage Weight Loss Pyridines Administration and Dosage Female Glycated Hemoglobin Metabolism Food Habits Human Energy Intake Male Dietary Supplements Single-Blind Studies Pyridines Pharmacodynamics Life Style Quality of Life Adult Middle Age Body Composition Obesity Drug Therapy Dose-Response Relationship, Drug Adolescence Young Adult Aged Body Mass Index Polysaccharides Pharmacodynamics Biological Assay Validation Studies Comparative Studies Evaluation Research Multicenter Studies Randomized Controlled Trials Short Form-36 Health Survey (SF-36) Questionnaires Adult: 19-44 years Middle Aged: 45-64 years Adolescent: 13-18 years Aged: 65+ years Female Male ab: Background: Chitosan is a dietary fibre which acts by reducing fat absorption and thus used as a means for controlling weight. Weight loss clinical trial outcomes, however, have contradictory results regarding its efficacy. 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.Methods: A phase IV, randomised, multicentre, single-blind, placebo-controlled, clinical study was conducted by administering chitosan capsules (500 mg, five/day) and indistinguishable placebo capsules as daily supplements to 96 overweight and obese subjects for 90 days. The study participants were divided in 2:1 ratio to receive either chitosan (n = 64) or placebo (n = 32). Efficacy was assessed by measuring body weight, body composition parameters, anthropometric measurements, HbA1C level and lipid profile at day 45 and day 90. 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. Safety was assessed by evaluating safety parameters and monitoring adverse events.Results: The mean changes in body weight were -1.78 ± 1.37 kg and -3.10 ± 1.95 kg at day 45 and day 90 respectively in chitosan group which were significantly different (p < 0.0001) as compared to placebo. BMI was decreased by10.91 fold compared to placebo after 90 day administration. In concert with this, there was also reduction in body composition and anthropometric parameters together with improvement in QoL score. Chitosan was also able to reduce HbA1C levels (below 6 %) in subjects who had initial higher values. The mean caloric intake shows that there was no change in dietary habits of subjects in both groups. Lipid levels were unaffected and all adverse events were mild in nature and unrelated to study treatment.Conclusion: Chitosan from fungal origin was able to reduce the mean body weight up to 3 kg during the 90 day study period. Together with this, there was also improvement in body composition, anthropometric parameters and HbA1C, reflecting overall benefits for the overweight individuals. Additionally, there was also improvement in QoL score. It was safe and well tolerated by all subjects.Trial Registration: CTRI/2014/08/004901. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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