title: Single-blind, placebo controlled randomised clinical study of chitosan for body weight reduction.
abstract: 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  CTRI/2014/08/004901.
authors.affiliation: Ethicare Clinical Trial Services, Titanium City Centre, 100 Feet Road, Ahmedabad, 380015, Ahmedabad, India. vandittrivedi@ethicare-cro.com.
authors.forename: V R
authors.initials: VR
authors.lastname: Trivedi
authors.affiliation: Ethicare Clinical Trial Services, Titanium City Centre, 100 Feet Road, Ahmedabad, 380015, Ahmedabad, India. milansatia@ethicare-cro.com.
authors.forename: M C
authors.initials: MC
authors.lastname: Satia
authors.affiliation: KITOZYME, Parc Industriel des Hauts-Sart, Zone 2, Rue de Milmort 680, 4040, Herstal, Belgium. a.deschamps@kitozyme.com.
authors.forename: A
authors.initials: A
authors.lastname: Deschamps
authors.affiliation: KITOZYME, Parc Industriel des Hauts-Sart, Zone 2, Rue de Milmort 680, 4040, Herstal, Belgium. v.maquet@kitozyme.com.
authors.forename: V
authors.initials: V
authors.lastname: Maquet
authors.affiliation: Poojan Multispecialty Hospital, Gurukul Road, Memnagar, Ahmedabad, 380052, India. poojan.research@gmail.com.
authors.forename: R B
authors.initials: RB
authors.lastname: Shah
authors.affiliation: DHL Research Centre, Nr. Shivranjani Cross Roads, Satellite, Ahmedabad, 380015, India. drpadmanabh@rediffmail.com.
authors.forename: P H
authors.initials: PH
authors.lastname: Zinzuwadia
authors.affiliation: SAL Hospital, Drive-in Road, Ahmedabad, 380054, India. drjvtrivedi@rediffmail.com.
authors.forename: J V
authors.initials: JV
authors.lastname: Trivedi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001823:Body Composition; D015992:Body Mass Index; D048271:Chitosan / Q000008:administration & dosage* / Q000494:pharmacology; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D023381:Endpoint Determination; D002149:Energy Intake; D005247:Feeding Behavior; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy; D050177:Overweight / Q000188:drug therapy; D011725:Pyridines / Q000008:administration & dosage* / Q000494:pharmacology; D011788:Quality of Life; D016037:Single-Blind Method; D015431:Weight Loss; D055815:Young Adult
chemical_list: D048271:Chitosan; D006442:Glycated Hemoglobin; D011725:Pyridines; C108850:V 10367