Influence of Tart Cherry Juice Intervention on Vascular Function

Influence of Tart Cherry Juice Intervention on Vascular Function and the Urinary Metabolite; a Preliminary Study to Inform Study Design

Diets containing fruit rich in anthocyanins have been shown (in meta-analyses) to be beneficial for health, but intervention trials have shown inconsistent results. In this preliminary study we want to investigate the influence of a tart-cherry juice intervention on vascular function and explore metabolite profiles that may offer insight into their mechanism of action

Study Overview

• Status: Completed
• Conditions: Metabolic Disturbance; Dietary Exposure
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Cherry juice

Detailed Description

Cardiovascular disease (CVD) is the primary cause of morbidity and mortality. Tart cherries (TC) can positively impact major risk factors of CVD, activities thought to be related to their phytochemical content. However, data from human trials is less clear. TC have been shown to reduce systolic blood pressure (SBP) after acute, short-term and chronic intake, and to improve vascular dysfunction, presumably due to their antioxidant and anti-inflammatory activities. Other studies have not shown benefits of TC on SBP or vascular function and studies are difficult to interpret with different populations, dosing and durations being used as well as a lack of understanding for any underlying mechanisms. To account for the latter, the use of metabolomics has become increasingly popular in nutritional research. Therefore, the aim of this preliminary study was to characterise the effects of TC supplementation on vascular function with a 4-week intervention and explore if metabolomics can provide mechanistic evidence and this will inform for future chronic studies with TC juice.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle Upon Tyne, United Kingdom, NE1 7ST
    • Northumberland Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• aged 19-40
• no diagnosed issues with the ability to consume fruit juice
• no known food intolerances to fruits

Exclusion Criteria:

• participants that are cigarette smokers
• participants diagnosed with hypertension
• participants diagnosed with any form of cardiometabolic diseases
• participants that require any prescribed prescriptions excluding the contraceptive pill
• participants that are regular consumers of cherries (>100 g/d)
• participants that consume any antioxidant supplements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants supplied with 30 ml of a low fruit (<1%) cordial mixed with maltodextrin and protein diluted in 100 ml water twice daily, once in the morning and evening.	Dietary supplement: Placebo; A tart cherry juice placebo
Experimental: Cherry juice; Participants supplied with 30 ml of a tart cherry juice concentrate (CherryActive, United Kingdom; (containing 36.8 mg of anthocyanins) diluted in 100 ml of water twice daily, once in the morning and evening.	Dietary supplement: Cherry juice; A tart cherry juice intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic and diastolic blood pressure	Measurement of systolic and diastolic blood pressure before and after the intervention	Change in blood pressure following 4 weeks intervention
Arterial pulse wave velocity	Measurement of pulse wave velocity before and after the intervention	Change in pulse wave velocity following 4 weeks intervention
Digital volume pulse	Measurement of digital volume pulse before and after the intervention	Change in digital volume pulse following 4 weeks intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolomics	Ion intensities of ca 5000 metabolites in urine samples before and after the intervention	Changes to urinary metabolite profiles following 4 weeks intervention

Collaborators and Investigators

• Sponsor: Northumbria University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: vascular function; anthocyanin; metabolomics; cherry
• Other Study ID Numbers: lucymurray2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Research data will be shared on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No