Influence of Tart Cherry Juice Intervention on Vascular Function

NCT ID: NCT04840160

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2019-08-01

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.

Conditions

Dietary Exposure; Metabolic Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

A tart cherry juice placebo

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.

Group Type: EXPERIMENTAL

Cherry juice

Intervention Type: DIETARY_SUPPLEMENT

A tart cherry juice intervention

Interventions

Cherry juice

A tart cherry juice intervention

Intervention Type: DIETARY_SUPPLEMENT

Placebo

A tart cherry juice placebo

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glyn Howatson

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

Northumberland Building

Newcastle upon Tyne, , United Kingdom

Countries

United Kingdom

Other Identifiers

lucymurray2016

Identifier Type: -

Identifier Source: org_study_id