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Completed

NCT Number: NCT02234648

To Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Vascular Function.

Given the global health issues associated with poor cardiovascular function, interventions that help reduce the severity, with emphasis on prevention would not only have economic implications, but would also improve health, wellbeing and quality of life. Research provides evidence that consumption of a diet high in plant foods and rich is polyphenols is associated with a reduction in the incidence of cardiovascular disease (Hung et al 2004). Tart Montmorency cherries have been shown to be high in numerous phytochemicals (Wang et al 1999; Seeram et al 2001). Several of these compounds, are known to be vasoactive and improve blood vessel function by increasing bioavailability of vasodilators (Mudnic et al 2012), reducing vasoconstrictors (Broncel et al 2010), decreasing platelet aggregation (Hubbart et al 2006) and increasing blood vessel dilation (Schroeter et al 2006). Impaired function of the lining of blood vessels (endothelial dysfunction) has been linked to increased risk of cardiovascular disease. However, the bioavailability of all the compounds in Tart Montmorency Cherry Juice and their efficacy with respect to vascular function has not been fully determined. This study will examine the influence of tart Montmorency cherry juice on cardiovascular function, specifically arterial stiffness by pulse wave velocity and blood flow in the microcirculation by laser Doppler imaging. This study will also examine digital volume pulse and pulse wave analysis. These data will provide information on the ability of TMCJ to affect blood flow and vascular function.

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Key information

Age range

21 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria University, Newcastle upon Tyne, Newcastle Upon Tyne, United Kingdom

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About this study

Participants provided blood samples immediately before supplementation and sequentially 8h post ingestion. Additionally, vascular measurements including laser Doppler imaging (LDI), pulse wave analysis (PWA), pulse wave velocity (PWV), digital volume pulse (DVP) and blood pressure (BP) were performed with the participant in a supine position. LDI, PWV, PWA, and DVP were measured at 1, 2, 3, 5 and 8h intervals. BP was performed at hourly intervals. All vascular measurements took place on the non - cannulated arm. No additional food or fluid was provided during the study period except for low-nitrate mineral water. Following a minimum of two weeks washout, the participants were required to return to the laboratory to repeat the procedure with the other intervention drink.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Those with blood pressure below 140/90
  • Males
  • Aged 21 - 55y

Exclusion criteria

  • Those with blood pressure above 140/90
  • Taken other medication/ supplements.
  • Those aged >21 or <55.

Treatment and study plan

60mL tart Montmorency cherry juice

Dietary Supplement

One bolus of 60mL of tart Montmorency concentrate mixed with 100mL of water.

Placebo

Other

One bolus of less than 5% fruit cordial mixed with water, maltodextrin and whey protein isolate to match for carbohydrate and calorie content of the juice.

Other names: less than 5% "Kia Ora" mixed fruit squash

Primary outcomes

  1. Changes in microvasculature blood flow

    Time frame: 0,1,2,3,5 and 8 hours

Secondary outcomes

  1. Changes in arterial stiffness

    Time frame: 0,1,2,3,5 and 8 hours

  2. Changes in blood pressure

    Time frame: 0,1,2,3,4,5,6,7 and 8 hours

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Registry information

Official study title

Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Vascular Function.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2014
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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