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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.

SUBMITTER: Sinclair J

PROVIDER: S-EPMC8466255 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Greater than one-third of adults in the United States have metabolic syndrome (MetS), a cluster of risk factors highly associated with the development of cardiovascular diseases. Premature vascular dysfunction in MetS may lead to accelerated age-related atherogenesis and arterial stiffening, thereby increasing cardiovascular risk. Montmorency tart cherries (Prunus cerasus L.) are rich in bioactive compounds, such as anthocyanins, known to exert cardiovascular protective effects. Previous research suggests that tart cherry juice consumption may improve cardiovascular health. The objective of this study was to evaluate the effects of daily consumption of tart cherry juice on hemodynamics, arterial stiffness, and blood biomarkers of cardiovascular and metabolic health in men and women with MetS. In a randomized, single-blind, placebo-controlled, parallel-arm pilot clinical trial, 19 men and women 20 to 60 years of age with MetS consumed 240 mL of tart cherry juice (Tart Cherry; n = 5 males, 4 females) or an isocaloric placebo-control drink (Control; n = 5 males, 5 females) twice daily for 12 weeks. Arterial stiffness (pulse wave velocity), brachial and aortic blood pressures, wave reflection (augmentation index), and blood biomarkers of cardiovascular and metabolic health were assessed at baseline and 6 and 12 weeks. Oxidized low-density lipoprotein and soluble vascular cell adhesion molecule-1 were significantly lower (P = .047 and P = .036, respectively) in Tart Cherry than Control at 12 weeks, but were not significantly lower than baseline values. There was a trend for total cholesterol to be lower (P = .08) in Tart Cherry than Control at 12 weeks. No significant changes were observed in hemodynamics, arterial stiffness, or other blood biomarkers assessed. These results suggest that daily tart cherry consumption may attenuate processes involved in accelerated atherogenesis without affecting hemodynamics or arterial stiffness parameters in this population. The pilot nature of this study warrants interpreting these findings with caution, and future clinical trials with a larger sample size are needed to confirm these findings.

Project description:Tart cherries possess properties that may reduce inflammation and improve glycemic control, however human data on supplementation and the gut microbiota is equivocal. Processing (i.e., juice concentrate, dried, frozen) may affect the properties of tart cherries, and therefore alter their efficacious health benefits. Therefore, the purpose of this study was to investigate the effect of 30 days of supplementation with Montmorency tart cherry (MTC) in concentrate or freeze-dried form on the gut microbiome and markers of inflammation and glycemic control. Healthy participants with no known disease (n = 58, age: 28 ± 10 y, height: 169.76 ± 8.55 cm, body mass: 72.2 ± 12.9 kg) were randomly allocated to four groups and consumed either concentrate or freeze-dried capsules or their corresponding placebos for 30 days. Venous blood samples were drawn at baseline, day 7, 14, and 30 and analyzed for inflammatory markers TNF-alpha, uric acid, C-reactive protein, and erythrocyte sedimentation rate and glycemic control markers glycated albumin, glucose and insulin. A fecal sample was provided at baseline, day 14 and 30 for microbiome analysis. TNF-alpha was significantly lower at 30 vs. 14 days (p = 0.01), however there was no other significant change in the inflammatory markers. Insulin was not changed over time (p = 0.16) or between groups (p = 0.24), nor was glycated albumin different over time (p = 0.08) or between groups (p = 0.56), however glucose levels increased (p < 0.001) from baseline (4.79 ± 1.00 mmol·L-1) to 14 days (5.21 ± 1.02 mmol·L-1) and 30 days (5.61 ± 1.22 mmol·L-1) but this was no different between groups (p = 0.33). There was no significant change in composition of bacterial phyla, families, or subfamilies for the duration of this study nor was there a change in species richness. These data suggest that 30 days of MTC supplementation does not modulate the gut microbiome, inflammation, or improve glycemic control in a healthy, diverse group of adults. Clinical Trail Registration:https://clinicaltrials.gov/ct2/show/NCT04467372, identifier: NCT04467372.

Project description:Background:Gout is a frequently occurring, complex rheumatologic form of inflammatory arthritis caused by the accumulation of serum uric acid (sUA) and deposition of uric acid crystals in the joints and tissues of the body. Hyperuricemia is also a significant independent risk factor for all-cause and cardiovascular morbidity and mortality and is associated with hypertension, diabetes, obesity, and osteoarthritis. However, patient adherence to prescribed urate-lowering therapies ranges from 20% to 70%, suggesting that other additional strategies, such as dietary intervention with specific, efficacious foods or beverages, may be necessary to mitigate the risk of arthritis, as well as other comorbidities. Tart cherry juice (TCJ) has been used for decades by some for gout based largely on anecdotal evidence of its efficacy and its antioxidant and anti-inflammatory properties. Objectives:We designed this study to test the effect of TCJ on uricemia, lipidemia, glycemia, and inflammation in at-risk overweight and obese humans with a specific hypothesis that TCJ consumption would reduce sUA concentrations. Methods:In this randomized, placebo-controlled crossover study, we recruited overweight and obese participants with body mass index (BMI) >25.0 kg/m2 (n = 26, 18 women/8 men, 41 ±11 y; BMI 31.3 ± 6.0; 12 obese, 14 overweight) to consume 240 mL/d (8 oz/d) of either TCJ or placebo beverage, for 4 wk each with a 4-wk intervening washout period followed by 4 wk of the alternate beverage. Results:TCJ significantly reduced sUA concentration by 19.2% (P < 0.05) and reduced by 19.4% (P = 0.09) and 6.3% (P = 0.08) proinflammatory high-sensitivity C-reactive protein and monocyte chemoattractant protein-1, respectively. The participants in this study displayed risk ratios indicating increased cardiovascular disease risk and insulin resistance but no differences in the pre- and postintervention groups of either placebo or TCJ groups. Conclusion:Collectively, the data suggest that 100% TCJ reduces sUA concentrations, mitigating hyperuricemia associated with gouty arthritis. This trial was registered at clinicaltrials.gov as NCT03636529.

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

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