Influence of Tart Cherry Juice Intervention on Vascular Function

Metabolic Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04840160
• Other study ID #: lucymurray2016
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: August 1, 2019

Study information

• Verified date: April 2021
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Exposure
• Metabolic Disturbance

Intervention

Dietary Supplement:
• Cherry juice
A tart cherry juice intervention
• Placebo
A tart cherry juice placebo

Locations

Country	Name	City	State
United Kingdom	Northumberland Building	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	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
Primary	Arterial pulse wave velocity	Measurement of pulse wave velocity before and after the intervention	Change in pulse wave velocity following 4 weeks intervention
Primary	Digital volume pulse	Measurement of digital volume pulse before and after the intervention	Change in digital volume pulse following 4 weeks intervention
Secondary	Metabolomics	Ion intensities of ca 5000 metabolites in urine samples before and after the intervention	Changes to urinary metabolite profiles following 4 weeks intervention