Effects of Montmorency Tart Cherry and Blueberry Juice on Cardiometabolic Outcomes in Healthy Individuals: Protocol for a 3-Arm Placebo Randomized Controlled Trial
Abstract
:Strengths and Limitations of this Study
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- This study will be the first randomized placebo-controlled trial to examine the effectiveness of both Montmorency tart cherry and blueberry juice on cardiometabolic outcomes.
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- Primary and secondary outcomes measures are central to the treatment of cardiometabolic disease and its comorbidities.
1. Introduction
1.1. Aims and Objectives
1.2. Hypotheses
2. Materials and Methods
2.1. Study Design and Setting
2.2. Participants
2.2.1. Inclusion Criteria
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- Eighteen years of age and above
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- Non-smoker
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- BMI < 30
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- Able to give informed consent
2.2.2. Exclusion Criteria
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- Pregnancy
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- Sixty-five years of age and above
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- Diabetes or any other metabolic/uncontrolled hypertensive conditions
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- Food allergies to cherries or blueberries
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- Habitual consumption of blueberries/cherries and/or blueberry/cherry products
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- Not regularly taking medication or antioxidant supplements
2.2.3. Sample Size
2.3. Recruitment
2.4. Dietary Intervention
2.5. Data Collection
2.5.1. Laboratory Visit Data
2.5.2. Anthropometric Measurements
2.5.3. Energy Expenditure and Substrate Oxidation
2.5.4. Haematological Testing
2.5.5. Blood Pressure and Resting Heart Rate
2.5.6. Questionnaires
2.6. Data Management
2.7. Statistical Analysis
3. Ethics and Dissemination
4. Conclusions and Limitations
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Conflicts of Interest
References
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Sinclair, J.; Shadwell, G.; Dillon, S.; Allan, R.; Butters, B.; Bottoms, L. Effects of Montmorency Tart Cherry and Blueberry Juice on Cardiometabolic Outcomes in Healthy Individuals: Protocol for a 3-Arm Placebo Randomized Controlled Trial. Int. J. Environ. Res. Public Health 2021, 18, 9759. https://doi.org/10.3390/ijerph18189759
Sinclair J, Shadwell G, Dillon S, Allan R, Butters B, Bottoms L. Effects of Montmorency Tart Cherry and Blueberry Juice on Cardiometabolic Outcomes in Healthy Individuals: Protocol for a 3-Arm Placebo Randomized Controlled Trial. International Journal of Environmental Research and Public Health. 2021; 18(18):9759. https://doi.org/10.3390/ijerph18189759
Chicago/Turabian StyleSinclair, Jonathan, Gareth Shadwell, Stephanie Dillon, Robert Allan, Bobbie Butters, and Lindsay Bottoms. 2021. "Effects of Montmorency Tart Cherry and Blueberry Juice on Cardiometabolic Outcomes in Healthy Individuals: Protocol for a 3-Arm Placebo Randomized Controlled Trial" International Journal of Environmental Research and Public Health 18, no. 18: 9759. https://doi.org/10.3390/ijerph18189759