title: Evaluation of plant based formulation on adolescent obesity and its associated bio-markers: a randomized, double blind, placebo controlled study.
abstract: OBJECTIVE
  Obesity and overweight are the fifth most fatal diseases leading to an increased rate of morbidity and mortality in global population, with its incidence increasing drastically. Taking this into consideration we have conducted the present study in order to explore the efficacy of plant based formulation in the management of adolescent obesity and its associated biomarkers.
  
  
  METHODS
  Randomized, double blind, placebo controlled trial was conducted in 130 obese adolescent of both sexes, with BMI above 25kg/m(2). The subjects were randomly assigned into test formulation group (TFG) and placebo group (PG). TFG received two 500mg capsule containing test formulation whereas, the PG received two 500mg of cellulose powder containing capsule daily for 3 months. The parameters such as blood pressure, inflammatory cytokines, adipokines and lipid profile were assessed in all subjects pre and post treatment.
  
  
  RESULTS
  There was a considerable improvement in the levels of lipid profile, inflammatory cytokines, adipokines and blood pressure after treatment in TFG compared to PG. The statistical difference obtained between the groups after three months of treatment for the various biomarkers are given as mean with 95% CI for BMI (-1.4±0.6 (-2.5 to -0.7)), total cholesterol mg/dl (-20.9±5.0 (-30.8 to -11.0)), triglyceride mg/dl (-12.9±5.7 (-23.9 to -1.2)), HDL-c mg/dl (7.2±0.8 (5.6-8.8)), IL-6 (-0.7±0.1 (-0.9 to -0.6)), hs C-reactive protein (CRP) mg/l(-1.0±0.01 (-1.2 to -0.8)), adiponectin µg/ml(4.9±0.4 (4.2-5.7)), leptin ng/ml (-8.0±1.4 (-10.7 to -5.3)), diastolic blood pressure (DBP) mmHg (-10.4±0.8 (-12.0 to -8.7)) and systolic blood pressure (SBP) mmHg (-6.7±0.7 (-8.1 to -5.3)). Also, there was a statistical significance within group TFG.
  
  
  CONCLUSIONS
  The study concludes that the test formulation may prevent the future cardio vascular risk incidence in obese adolescents by reducing inflammation, overweight, lipid profile and by regulating adipokines. Thus it may help to improve the health pattern in obese patients with least side effects.
authors.affiliation: ISISM, SRM University, Kattankulathur, Chennai, India. Electronic address: spsk99@gmail.com.
authors.forename: S
authors.initials: S
authors.lastname: Shivakumar
authors.affiliation: ISISM, SRM University, Kattankulathur, Chennai, India.
authors.forename: K
authors.initials: K
authors.lastname: Ilango
authors.affiliation: Department of Kriya Sharir, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.
authors.forename: G P
authors.initials: GP
authors.lastname: Dubey
authors.affiliation: ISISM, SRM University, Kattankulathur, Chennai, India.
authors.forename: N
authors.initials: N
authors.lastname: Subhasree
authors.affiliation: Department of Kriya Sharir, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India. Electronic address: arunaagrawal12@gmail.com.
authors.forename: Aruna
authors.initials: A
authors.lastname: Agrawal
mesh_terms: D000293:Adolescent; D015415:Biomarkers / Q000097:blood*; D002648:Child; D004311:Double-Blind Method; D004435:Eating / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D063766:Pediatric Obesity / Q000097:blood* / Q000188:drug therapy*; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D015415:Biomarkers; D010936:Plant Extracts
keywords: Adipokines; Inflammation; Lipid profile; Obesity; Randomized; Test formulation