Abstract

Cardiometabolic disease is recognized as the predominant cause of global mortality and healthcare expenditure. Whilst pharmaceutical interventions are effective in the short term, their long-term efficacy remain equivocal and their associated side-effects are concerning. Owing to their high levels of anthocyanins, Montmorency tart cherries and blueberries have been cited as potentially important natural treatment/preventative modalities for cardiometabolic disease. This study proposed a randomized controlled trial, aims to test the effects of consumption of Montmorency tart cherry and blueberry juice on cardiometabolic outcomes compared to placebo. This 20-day, parallel, single-blind, randomized, placebo-controlled trial will recruit 45 individuals, who will be assigned to receive 60 mL per day of either Montmorency tart cherry juice, blueberry juice or a cherry/blueberry flavoured placebo. The primary study outcome is the between-group difference in systolic blood pressure from baseline to post-intervention. Secondary outcome measures will be between-group differences in anthropometric, energy expenditure and substrate oxidation (during rest and physical activity), haematological, blood pressure/resting heart rate, psychological wellbeing and sleep efficacy indices. Statistical analysis will be conducted on an intention-to-treat basis. This study has been granted ethical approval by the University of Central Lancashire, Health Research Ethics Committee (ref: HEALTH 0016) and formally registered as a trial. Dissemination of the study findings from this investigation will be through publication in a leading peer-reviewed journal.

Highlights

  • Cardiovascular conditions, type 2 diabetes mellitus and other associated cardiometabolic disease modalities are recognized as the predominant causes of global mortality and healthcare expenditure [1]

  • In relation to the primary outcome, both Montmorency tart cherry and blueberry supplement groups will mediate reductions in systolic blood pressure compared to the placebo, but no differences will be observed between supplement groups

  • For the secondary outcomes, the Montmorency tart cherry and blueberry groups will produce improvements in cardiometabolic health parameters compared to the placebo, but there will be no differences between the two supplement groups

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Summary

Introduction

Cardiovascular conditions, type 2 diabetes mellitus and other associated cardiometabolic disease modalities are recognized as the predominant causes of global mortality and healthcare expenditure [1]. Whilst administration of these medications is effective in the treatment, postponement and prevention of cardiometabolic disease, their longitudinal effects and cost-effectiveness has yet to be corroborated [6], and significant negative sideeffects remain common [7]. These side effects paired with recent findings show that globally. The efficacy of improved habitual dietary practice on cardiometabolic health is unambiguous, to the extent that medical organizations recommend this as the primary approach for the prevention and management of cardiometabolic disease [9]. With some food biochemical investigations showing that anthocyanin contents in dark fruits such as blueberries are as high or even greater than in tart cherries [16], further such investigations may be of both practical and clinical relevance

Aims and Objectives
Hypotheses
Study Design and Setting
Inclusion
Recruitment
Laboratory Visit Data
Anthropometric Measurements
Energy Expenditure and Substrate Oxidation
Haematological Testing
Blood Pressure and Resting Heart Rate
Questionnaires
Data Management
Statistical Analysis
Ethics and Dissemination
Conclusions and Limitations

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