Effects of Montmorency Tart Cherry and Blueberry Juice on Cardiometabolic Outcomes in Healthy Individuals: Protocol for a 3-Arm Placebo Randomized Controlled Trial

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.

The efficacy of a tart cherry drink for the treatment of patellofemoral pain in recreationally active individuals: a placebo randomized control trial

“…Descriptive statistics of means and standard deviations were obtained for each outcome measure. Comparisons between groups for continuous participant characteristics at baseline, all of the experimental variables at baseline, the amount of supplement consumed, % compliance, supplemental anthocyanins, supplemental phenolics, supplemental energy intake, supplemental sugars, and weekly exercise during the intervention were undertaken using linear mixed-effects models, with group modelled as a fixed factor and random intercepts by participants [56]. To determine the effects of the intervention on questionnaire, blood biomarkers, knee proprioception, knee biomechanics, and dietary variables between the two groups, linear mixed-effects models were adopted, with group again modelled as a fixed factor and random intercepts by participants, adjusting for baseline values [56,57].…”

“…Blinding efficacy was also examined using a one-way chi-squared goodness of fit test. Finally, 2 × 2 Pearson chi-square tests of independence were also used to test for differences in binary outcomes, i.e., lost to follow-up (yes/ no) and adverse outcomes (yes/no) during the intervention in each group and similarly to contrast categorical baseline outcomes between groups, i.e., sex (male/female) and ethnicity (Caucasian/Asian) between groups [56]. All analyses were conducted using SPSS v27 (IBM, SPSS, Armonk, NY: IBM Corp), and statistical significance for all analyses was accepted as the P ≤ 0.05 level.…”

Effects of Montmorency Tart Cherry and Blueberry Juice on Cardiometabolic and Other Health-Related Outcomes: A Three-Arm Placebo Randomized Controlled Trial

“…Cardiometabolic disease is now the principal cause of global mortality and healthcare expenditure [1]. Cardiometabolic syndrome itself is characterized by a range of symptoms, including hypertension, insulin resistance, atherogenic dyslipidemia, low high-density lipoproteins, high triglycerides, high adiposity, high body mass index, large waist-to-hip ratio, and poor glucose regulation [2,3]. Within the epidemiological literature, distinct pathophysiological markers of oxidative stress, nitric oxide, and inflammation have been cited as being the mechanistic indicators associated with the clinical presentation of cardiometabolic disease [4,5].…”

“…Globally, it has been documented that 84% of adults over the age of 57 are prescribed at least one medication per day [9]. As such, it is clear that further natural and cost-effective remedies are required for cardiometabolic disease management and prevention [3].…”

Perceptions, beliefs and behaviors of nutritional and supplementary practices in inflammatory bowel disease

“…Bilberry supplementation has importantly shown significant improvements in biological and self-reported quality of life in human UC patients [25]. Montmorency tart cherries are the richest source of polyphenols [30,31] and may, therefore, have significant potential as natural supplementary agents in IBD patients. Intervention trials using tart cherries for IBD have not yet been considered, and patient perceptions regarding their willingness to take this supplement are currently unknown.…”