Clinical trial NCT04840160: Influence of Tart Cherry Juice Intervention on Vascular Function
Official title: Influence of Tart Cherry Juice Intervention on Vascular Function and the Urinary Metabolite; a Preliminary Study to Inform Study Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Exposure
Metabolic Disturbance
Keywords: cherry
anthocyanin
vascular function
metabolomics
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 23
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: Change in blood pressure following 4 weeks intervention
measure: Arterial pulse wave velocity
timeFrame: Change in pulse wave velocity following 4 weeks intervention
measure: Digital volume pulse
timeFrame: Change in digital volume pulse following 4 weeks intervention
Secondary outcomes:
measure: Metabolomics
timeFrame: Changes to urinary metabolite profiles following 4 weeks intervention
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumberland Building
Study officials:
affiliation: Northumbria University
name: Glyn Howatson
role: PRINCIPAL_INVESTIGATOR
References: