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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234648
• Other study ID #: NUKK1
• Status: Completed
• Phase: N/A
• First received: September 1, 2014
• Last updated: April 13, 2015
• Start date: August 2014
• Est. completion date: October 2014

Study information

• Verified date: April 2015
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• 60mL tart Montmorency cherry juice
One bolus of 60mL of tart Montmorency concentrate mixed with 100mL of water.

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.

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle Upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in microvasculature blood flow		0,1,2,3,5 and 8 hours	No
Secondary	Changes in arterial stiffness		0,1,2,3,5 and 8 hours	No
Secondary	Changes in blood pressure		0,1,2,3,4,5,6,7 and 8 hours	No