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

NCT ID: NCT02234648

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-10-31

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.

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

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),

Group Type: ACTIVE_COMPARATOR

60mL tart Montmorency cherry juice

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

60mL tart Montmorency cherry juice

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Other Intervention Names

less than 5% "Kia Ora" mixed fruit squash

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Glyn Howatson

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Glyn Howatson

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

Northumbria University

Newcastle upon Tyne, Newcastle Upon Tyne, United Kingdom

Northumbria University

Newcastle upon Tyne, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 27146650 (View on PubMed)

Other Identifiers

NUKK1

Identifier Type: -

Identifier Source: org_study_id