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  • Does supplementation with carnosine improve cardiometabolic health and cognitive function in patients with pre-diabetes and type 2 diabetes? study protocol for a randomised, double-blind, placebo-controlled trial

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Diabetes and endocrinology
Protocol
Does supplementation with carnosine improve cardiometabolic health and cognitive function in patients with pre-diabetes and type 2 diabetes? study protocol for a randomised, double-blind, placebo-controlled trial
  1. Estifanos Baye1,
  2. Kirthi Menon1,
  3. Maximilian PJ de Courten2,
  4. Arul Earnest3,
  5. James Cameron4,
  6. Barbora de Courten1,5
  1. 1 Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
  2. 2 Centre for Chronic Disease, College of Health and Biomedicine, Victoria University, Melbourne, Victoria, Australia
  3. 3 Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
  4. 4 Monash Cardiovascular Research Centre, Monash Heart, Monash Health, Melbourne, Victoria, Australia
  5. 5 Diabetes and Vascular Medicine Unit, Monash Health, Melbourne, Victoria, Australia
  1. Correspondence to Professor Barbora de Courten; barbora.decourten{at}monash.edu

Abstract

Introduction Carnosine, an over-the-counter food supplement, has a promising potential for the prevention and treatment of chronic diseases such as type 2 diabetes (T2DM), cardiovascular and neurodegenerative diseases through its anti-inflammatory, antiglycation, antioxidative and chelating effects. We have previously shown that supplementation with carnosine preserves insulin sensitivity and secretion in non-diabetic overweight and obese individuals. The effect of carnosine on cardiometabolic risk and related cognitive outcomes in patients with pre-diabetes and T2DM has thus far not been studied. We therefore aim to investigate whether supplementation with carnosine improves cardiometabolic health and cognitive function in patients with pre-diabetes and T2DM.

Methods and analysis We will employ a parallel design randomised controlled trial. Fifty participants with pre-diabetes (impaired fasting glycaemia and impaired glucose tolerance) and T2DM (with HbA1c level < 8%) aged between 18 to 70 years will be randomly assigned to the intervention or control group. At baseline, participants will undergo a medical review and series of tests including anthropometric measurements (body mass index, a dual X-ray absorptiometry and peripheral quantitative computed tomography scan), an oral glucose tolerance test, cardiovascular measurements (central blood pressure, endothelial function and arterial stiffness), cognitive function, physical activity measurement, heart rate variability and liver fibroscan as well as questionnaires to assess dietary habits, sleep quality, depression and quality of life. The intervention group will receive 2 g of carnosine daily in two divided doses while the control group will receive identical placebo capsules for 14 weeks. All baseline measurements will be repeated at the end of the intervention. The change in glycaemic, cardiovascular and cognitive parameters as well as other measures will be compared between the groups.

Ethics and dissemination This study is approved by the Human Research Ethics Committee of Monash Health and Monash University, Australia. The findings will be disseminated via peer-reviewed publications and conference presentations.

Trial registration NCT02917928; Pre-results.

  • general diabetes
  • other metabolic, e.g. iron, porphyria
  • lipid disorders

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-017691

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    Footnotes

    • Contributors EB involved in the conception and development of the study protocol, wrote the first draft of the manuscript and revised the subsequent drafts. KM involved in the development of the study and critical revision of the manuscript. BdC conceived and developed the study protocol, and co-wrote the manuscript with EB. JC and MPJdC contributed to the conception and development of the study protocol, and critical revision of the manuscript. AE provided input on the sample size and analysis plan, and critical revision of the manuscript. All authors read and approved the manuscript.

    • Funding This study is supported by the Royal Australasian College of Physicians, Diabetes Australia Research Trust, Foundation for High Blood Pressure Research, CASS foundation, Australian National Heart Foundation and Australian Diabetes Society. Carnosine supplement (CarnopureTM) is received from Flamma S.p.A, Italy. These funding bodies have no role in the design of the study and collection, analysis, and interpretation of data and in writing of the manuscript.

    • Competing interests None declared.

    • Ethics approval Monash Health and Monash University, Melbourne, Australia.

    • Provenance and peer review Not commissioned; externally peer reviewed.