Curcumin and long-chain Omega-3 polyunsaturated fatty acids for Prevention of type 2 Diabetes (COP-D): study protocol for a randomised controlled trial.

Rohith N Thota,Shamasunder H Acharya,Manohar L Garg,Kylie A Abbott

doi:10.1186/s13063-016-1702-9

Abstract

BackgroundLifestyle 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.Methods/designEighty 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.DiscussionThis 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.Trial registration ACTRN12615000559516, registered on 29 May 2015).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1702-9) contains supplementary material, which is available to authorized users.

Highlights

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
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
Lifestyle modifications alone are insufficient to bring down the prevalence of prediabetes, so there is a need for long-term, safe and cost-effective agents that can act through multiple mechanisms to improve insulin sensitivity and beta-cell function

Summary

Introduction

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. People with prediabetes, who are at a high risk of developing T2D, have intermediate glucose levels that are elevated but not high enough to be diagnosed as T2D. They are classed as having either impaired glucose tolerance (IGT), impaired fasting glucose (IFG) or both. An elevated level of subclinical inflammation for prolonged periods is believed to be the primary trigger preceding all of the above mechanisms [14]. These pathological mechanisms mediate a reduction in insulin-stimulated glucose uptake leading to insulin resistance. Present throughout the prediabetic stage, acts as a conduit between the progression of the subclinical inflammatory state to T2D

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