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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Placebo; Dietary supplement: 60mL tart Montmorency cherry juice

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle Upon Tyne, United Kingdom, NE1 8ST
    • Northumbria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in microvasculature blood flow	0,1,2,3,5 and 8 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in arterial stiffness	0,1,2,3,5 and 8 hours
Changes in blood pressure	0,1,2,3,4,5,6,7 and 8 hours

Collaborators and Investigators

• Sponsor: Northumbria University

Publications and helpful links

General Publications

• Keane KM, George TW, Constantinou CL, Brown MA, Clifford T, Howatson G. Effects of Montmorency tart cherry (Prunus Cerasus L.) consumption on vascular function in men with early hypertension. Am J Clin Nutr. 2016 Jun;103(6):1531-9. doi: 10.3945/ajcn.115.123869. Epub 2016 May 4.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: September 1, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (ESTIMATE): September 9, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 13, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Arterial Stiffness; Vascular Function; Blood Flow; tart Montmorency cherries
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: NUKK1