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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02234648
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Glyn Howatson, Northumbria University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Dietary Supplement: 60mL tart Montmorency cherry juice Other: Placebo Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Vascular Function.
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
The PLA supplement consisted of a commercially available, less than 5% fruit, cordial (Protein - Trace, Carbohydrate 260 mg•mL-1, Sodium 0.02 mg•mL-1, Fibre-Trace and Anthocyanins-Trace for colour), mixed with water, whey protein isolate (Arla Foods Ltd., Leeds, UK) and maltodextrin (MyProtein Ltd., Northwich, UK) until matched for carbohydrate and calorie content of the MC.
Other: Placebo
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 Name: less than 5% "Kia Ora" mixed fruit squash

Active Comparator: 60mL tart Montmorency cherry juice
One bolus of 60mL of tart Montmorency cherry (MC) juice mixed with 100mL of water. Independent analysis of MC (Atlas Biosciences, 2010) provided the following compositional data; Fat 0.028 mg•mL-1, Protein 31.47 mg•mL-1, Carbohydrate 669.4 mg•mL-1, Cholesterol < 0.01 mg•mL-1, Sodium 0.691 mg•mL-1, Calcium 0.137 mg•mL-1 and Iron 0.026 mg•mL-1. Additionally, according to the manufacturers guidelines (Cherry Active, Hanworth, UK),
Dietary Supplement: 60mL tart Montmorency cherry juice
One bolus of 60mL of tart Montmorency concentrate mixed with 100mL of water.




Primary Outcome Measures :
  1. Changes in microvasculature blood flow [ Time Frame: 0,1,2,3,5 and 8 hours ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234648


Locations
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United Kingdom
Northumbria University
Newcastle Upon Tyne, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Investigators
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Principal Investigator: Glyn Howatson Northumbria University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Glyn Howatson, Dr., Northumbria University
ClinicalTrials.gov Identifier: NCT02234648    
Other Study ID Numbers: NUKK1
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015
Keywords provided by Glyn Howatson, Northumbria University:
Vascular Function
tart Montmorency cherries
Arterial Stiffness
Blood Flow
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases