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Completed

NCT Number: NCT04840160

Influence of Tart Cherry Juice Intervention on Vascular Function

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

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Key information

Age range

19 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumberland Building

Newcastle upon Tyne, NE1 7ST, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cherry juice

Dietary Supplement

A tart cherry juice intervention

Placebo

Dietary Supplement

A tart cherry juice placebo

Primary outcomes

  1. Systolic and diastolic blood pressure

    Time frame: Change in blood pressure following 4 weeks intervention

    Measurement of systolic and diastolic blood pressure before and after the intervention

  2. Arterial pulse wave velocity

    Time frame: Change in pulse wave velocity following 4 weeks intervention

    Measurement of pulse wave velocity before and after the intervention

  3. Digital volume pulse

    Time frame: Change in digital volume pulse following 4 weeks intervention

    Measurement of digital volume pulse before and after the intervention

Secondary outcomes

  1. Metabolomics

    Time frame: Changes to urinary metabolite profiles following 4 weeks intervention

    Ion intensities of ca 5000 metabolites in urine samples before and after the intervention

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Apr 9, 2021
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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