Dietary ExposureNCT04840160
Influence of Tart Cherry Juice Intervention on Vascular Function
A study testing Cherry juice in people with Dietary Exposure and Metabolic Disturbance, run by Northumbria University at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Exposure, Metabolic Disturbance
- What is being tested?
- Cherry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2016to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 19-40
- no diagnosed issues with the ability to consume fruit juice
- no known food intolerances to fruits
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumberland Building
Newcastle upon Tyne, NE1 7ST
About this study
Official title: 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
Read the 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
- Being tested
- Cherry juice, Placebo
- Keywords
- cherry, anthocyanin, vascular function, metabolomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cherry juiceDietary supplement
A tart cherry juice intervention
PlaceboDietary supplement
A tart cherry juice placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
| Cherry juice | Experimental | 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. Receives: Dietary Supplement: Cherry juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic blood pressure
Measurement of systolic and diastolic blood pressure before and after the intervention
Measured: Change in blood pressure following 4 weeks intervention
Arterial pulse wave velocity
Measurement of pulse wave velocity before and after the intervention
Measured: Change in pulse wave velocity following 4 weeks intervention
Digital volume pulse
Measurement of digital volume pulse before and after the intervention
Measured: Change in digital volume pulse following 4 weeks intervention
Secondary outcomes (1)
Metabolomics
Ion intensities of ca 5000 metabolites in urine samples before and after the intervention
Measured: Changes to urinary metabolite profiles following 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Apr 2016
- Primary completion1 Aug 2017
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glyn Howatson, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840160
- Sponsor's protocol ID
- lucymurray2016
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research data will be shared on request
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Tart Cherry Juice Intervention on Vascular Function and the Urinary Metabolite; a Preliminary Study to Inform Study Design
- ClinicalTrials.gov ID
- NCT04840160
- Acronym / sponsor ID
- lucymurray2016
- Conditions
- Dietary Exposure, Metabolic Disturbance
- Keywords
- cherry, anthocyanin, vascular function, metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
| Cherry juice | Experimental | Dietary Supplement: Cherry juiceParticipants 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. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 19-40
- no diagnosed issues with the ability to consume fruit juice
- no known food intolerances to fruits
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cherry juiceA tart cherry juice intervention | Dietary supplement | Cherry juice |
| PlaceboA tart cherry juice placebo | Dietary supplement | Placebo |
Primary outcome
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
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
Digital volume pulse
Time frame: Change in digital volume pulse following 4 weeks intervention
Measurement of digital volume pulse before and after the intervention
1 secondary outcome
Metabolomics
Time frame: Changes to urinary metabolite profiles following 4 weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: No. Research data will be shared on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glyn Howatson principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cherry juice in people with Dietary Exposure and Metabolic Disturbance, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and diastolic blood pressure (time frame: Change in blood pressure following 4 weeks intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.