title: Curcumin and long-chain Omega-3 polyunsaturated fatty acids for Prevention of type 2 Diabetes (COP-D): study protocol for a randomised controlled trial.
abstract: Lifestyle interventions, including increase in physical activity and dietary counselling, have shown the ability to prevent type 2 diabetes (T2D) in high-risk state individuals, but the prevalence is still skyrocketing in Australia, in line with global prevalence. Currently, no medicines are approved by the Therapeutic Goods Administration in Australia for the management of prediabetes. Therefore, there is a need of developing a safer, biologically efficacious and cost-effective alternative for delaying the transition of individual health state from prediabetes into T2D. In the current trial we propose to evaluate the effects of curcumin and/or long-chain omega-3 polyunsaturated fatty acids on improving glycosylated haemoglobin as a primary outcome, along with secondary outcomes of glycaemic indices, lipid profile and inflammatory parameters.
  
  
  
  Eighty individuals diagnosed with prediabetes, aged between 30 and 70 years, will be randomly assigned to double placebo, curcumin alone, fish oil alone or double active groups according to a computer-generated randomisation sequence for 12 weeks. At baseline and post-intervention visits participants will be asked to provide blood samples and undergo body composition measurements. A blood sample is used for estimating glycaemic profiles, lipid profiles and inflammatory parameters (C-reactive protein, whole blood cell count, adiponectin, leptin, interleukin-6). The interim visit includes review on compliance with supplements based on capsule log and capsule count, adverse events and anthropometric measurements. In addition to these procedures, participants provide self-reported questionnaires on dietary intake (using a 3-day food record), a physical activity questionnaire and medical history.
  
  
  
  This trial aims to determine whether curcumin and/or long-chain omega-3 polyunsaturated fatty acids affect surrogate markers of glycaemic control which is relevant to delaying T2D. To date 38 participants completed the trial. No changes have been made to the clinical protocol post recruitment. If successful, this trial will provide considerable evidence for performing a larger trial to investigate whether this combination can be administered for preventing or delaying the onset of T2D in high-risk individuals.
  
  
  
  ACTRN12615000559516 , registered on 29 May 2015).
authors.affiliation: Nutraceuticals Research Group, School of Biomedical Sciences and Pharmacy, University of Newcastle, 305C Medical Sciences Building, Callaghan, NSW, 2308, Australia.
authors.forename: Rohith N
authors.initials: RN
authors.lastname: Thota
authors.affiliation: Department of Endocrinology, John Hunter Hospital, Hunter New England Local Health District, New Lambton Heights, NSW, Australia.
authors.forename: Shamasunder H
authors.initials: SH
authors.lastname: Acharya
authors.affiliation: Nutraceuticals Research Group, School of Biomedical Sciences and Pharmacy, University of Newcastle, 305C Medical Sciences Building, Callaghan, NSW, 2308, Australia.
authors.forename: Kylie A
authors.initials: KA
authors.lastname: Abbott
authors.affiliation: Nutraceuticals Research Group, School of Biomedical Sciences and Pharmacy, University of Newcastle, 305C Medical Sciences Building, Callaghan, NSW, 2308, Australia. manohar.garg@newcastle.edu.au.
authors.forename: Manohar L
authors.initials: ML
authors.lastname: Garg
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D001823:Body Composition; D002985:Clinical Protocols; D003474:Curcumin / Q000009:adverse effects / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015525:Fatty Acids, Omega-3 / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D009517:New South Wales; D011236:Prediabetic State / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D012107:Research Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D003474:Curcumin; D015525:Fatty Acids, Omega-3; D006442:Glycated Hemoglobin; D018836:Inflammation Mediators; D008055:Lipids; C517652:hemoglobin A1c protein, human
keywords: Curcumin; Docosahexaenoic acid; Eicosapentaenoic acid; Inflammation; Insulin sensitivity; Omega-3 fatty acids; Prediabetes and type 2 diabetes