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

NCT02234648 | Completed DMC

• 1 other identifier: NUKK1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension

Keywords

Vascular Function; tart Montmorency cherries; Arterial Stiffness; Blood Flow

Outcome Measures

Primary Outcomes (1)

• Changes in microvasculature blood flow

  0,1,2,3,5 and 8 hours

Secondary Outcomes (2)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

60mL tart Montmorency cherry juice

ACTIVE COMPARATOR

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

Interventions

60mL tart Montmorency cherry juice DIETARY_SUPPLEMENT

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

60mL tart Montmorency cherry juice

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.

Also known as: less than 5% "Kia Ora" mixed fruit squash

Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (2)

Northumbria University

Newcastle upon Tyne, Newcastle Upon Tyne, NE1 8ST, United Kingdom

Location

Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27146650 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Glyn Howatson

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 1, 2014
• First Posted: September 9, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

GB (2)