Cardiometabolic Risk FactorsNCT04021342
The Effect of Tart Cherry (Prunus Cerasus) Concentrate on Physiological and Cognitive Function
A study testing Montmorency tart cherry concentrate in people with Cardiometabolic Risk Factors and Cognitive Function, run by Northumbria University at 1 site in United Kingdom.
Trial summary
A randomized, double blind, counterbalanced, placebo controlled independent groups design to determine the effects of 3 month supplementation with tart cherry concentrate on indices of cardiometabolic health, exercise capacity and cognitive function. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk Factors, Cognitive Function, Exercise Capacity
- What is being tested?
- Montmorency tart cherry concentrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Oct 2018to 29 Feb 2020
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals between the ages of 40-60 years
- consume on average ≤5 servings of fruits and vegetables per day
- additionally have ≥1 risk factor for type 2 diabetes
Who cannot join
- not regularly taking medication (or stabilised ≥ 3 months, with no adverse symptoms) or antioxidant supplements
- history of cardiometabolic, gastointestinal disease or malabsorption syndromes
- stage 2 hypertension (SBP >159 mm Hg or DBP >99 mm Hg)
- individuals who report changes in dietary or physical activity patterns within 3 months
- vegetarians, vegans or known eating disorders
- alcohol intake of more than 21 units per week
- BMI ≥40 kg/m2
- are pregnant or planning to become pregnant during the study, lactating, or initiating or changing a hormone replacement therapy regimen within 3 months of the start of the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, NE18ST
About this study
Official title: The Effect of Tart Cherry (Prunus Cerasus) Concentrate on Cardiometabolic Risk Factors, Exercise Capacity and Cognitive Function
A randomized, double blind, counterbalanced, placebo controlled independent groups design to determine the effects of 3 month supplementation with tart cherry concentrate on indices of cardiometabolic health, exercise capacity and cognitive function. Following screening and recruitment, participants are familiarised with the testing equipment and procedures after which they will be randomly assigned to receive either Montmorency tart cherry concentrate (MC) or an isocaloric placebo (PLA), stratified by gender. The study is comprised of two experimental visits and outcome variables are assessed at baseline (before supplementation) and at 3 months (follow up; after supplementation).
- Being tested
- Montmorency tart cherry concentrate, Placebo
- Keywords
- Tart cherry, Montmorency cherries, Prunus Cerasus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montmorency tart cherry concentrateDietary supplement
Based on previous analysis done by our laboratory each 60 ml of Montmorency tart cherry concentrate contains approximately 73.5 mg of anthocyanins (cyanidin-3-glucoside equivalents) and 178.8 mg of total phenolics (mean gallic acid equivalents)
PlaceboDietary supplement
Placebo beverage matched for calorie content and visual properties of the cherry concentrate
| Study group | Role | What they receive |
|---|---|---|
| Montmorency tart cherry concentrate | Active comparator | Participants will consume 30 ml of Montmorency tart cherry concentrate (MC) concentrate (King Orchard farms, USA) twice daily, once in the morning and again in the evening. According to the manufacturer each 30 ml dose of MC is estimated to be equivalent to approximately 90 whole cherries (equating to ~180 cherries per day). Receives: Dietary Supplement: Montmorency tart cherry concentrate |
| Isocaloric cherry flavoured placebo | Placebo comparator | The PLA is prepared by mixing by mixing unsweetened black cherry flavoured Kool-Aid (Kraft Foods, United States), dextrose, fructose with water to best match the calorie content of the MC concentrate. Additional lemon juice, for tartness, and artificial food colouring is added so the final product had a similar visual properties to the active comparator. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg)
Measured: Change from baseline at 3 months
Arterial Stiffness
Pulse wave velocity (m/s)
Measured: Change from baseline at 3 months
Arterial Stiffness
Augmentation index (%)
Measured: Change from baseline at 3 months
Endothelial function
Flow mediated dilation (% change)
Measured: Change from baseline at 3 months
Secondary outcomes (6)
Indices of metabolic health
glucose (mmol/L) triglycerides (mmol/L) LDL cholesterol (mmol/L) HDL cholesterol (mmol/L)
Measured: Change from baseline at 3 months
Cognitive function
Computerized cognitive function assessment percentage accuracy (%)
Measured: Change from baseline at 3 months
Cognitive function
Computerized cognitive function assessment reaction time (m/s)
Measured: Change from baseline at 3 months
Cerebral Blood flow
Oxygenated heamoglobin (Oxyhb)
Measured: Change from baseline at 3 months
Cerebral Blood flow
Deoxygenated heamoglobin (deoxyhb)
Measured: Change from baseline at 3 months
Exercise Capacity
Estimated aerobic exercise capacity (VO2max) measured by a submaximal cycling test
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start12 Oct 2018
- Primary completion29 Nov 2019
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Risk FactorsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Cherry Marketing Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021342
- Sponsor's protocol ID
- 4240
- Status last verified
- Apr 2021
- First submitted
- 29 May 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tart Cherry (Prunus Cerasus) Concentrate on Cardiometabolic Risk Factors, Exercise Capacity and Cognitive Function
- ClinicalTrials.gov ID
- NCT04021342
- Acronym / sponsor ID
- 4240
- Keywords
- Tart cherry, Montmorency cherries, Prunus Cerasus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Cherry Marketing Institute
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 16 Jul 2019 (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.
A randomized, double blind, counterbalanced, placebo controlled independent groups design to determine the effects of 3 month supplementation with tart cherry concentrate on indices of cardiometabolic health, exercise capacity and cognitive function. Following screening and recruitment, participants are familiarised with the testing equipment and procedures after which they will be randomly assigned to receive either Montmorency tart cherry concentrate (MC) or an isocaloric placebo (PLA), stratified by gender. The study is comprised of two experimental visits and outcome variables are assessed at baseline (before supplementation) and at 3 months (follow up; after supplementation).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montmorency tart cherry concentrate | Active comparator | Dietary Supplement: Montmorency tart cherry concentrateParticipants will consume 30 ml of Montmorency tart cherry concentrate (MC) concentrate (King Orchard farms, USA) twice daily, once in the morning and again in the evening. According to the manufacturer each 30 ml dose of MC is estimated to be equivalent to approximately 90 whole cherries (equating to ~180 cherries per day). |
| Isocaloric cherry flavoured placebo | Placebo comparator | Dietary Supplement: PlaceboThe PLA is prepared by mixing by mixing unsweetened black cherry flavoured Kool-Aid (Kraft Foods, United States), dextrose, fructose with water to best match the calorie content of the MC concentrate. Additional lemon juice, for tartness, and artificial food colouring is added so the final product had a similar visual properties to the active comparator. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy individuals between the ages of 40-60 years
- consume on average ≤5 servings of fruits and vegetables per day
- additionally have ≥1 risk factor for type 2 diabetes
Key exclusion criteria (8 listed)
- not regularly taking medication (or stabilised ≥ 3 months, with no adverse symptoms) or antioxidant supplements
- history of cardiometabolic, gastointestinal disease or malabsorption syndromes
- stage 2 hypertension (SBP >159 mm Hg or DBP >99 mm Hg)
- individuals who report changes in dietary or physical activity patterns within 3 months
- vegetarians, vegans or known eating disorders
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 |
|---|---|---|
| Montmorency tart cherry concentrateBased on previous analysis done by our laboratory each 60 ml of Montmorency tart cherry concentrate contains approximately 73.5 mg of anthocyanins (cyanidin-3-glucoside equivalents) and 178.8 mg of total phenolics (mean gallic acid equivalents) | Dietary supplement | Montmorency tart cherry concentrate |
| PlaceboPlacebo beverage matched for calorie content and visual properties of the cherry concentrate | Dietary supplement | Isocaloric cherry flavoured placebo |
Primary outcome
Blood pressure
Time frame: Change from baseline at 3 months
Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg)
Arterial Stiffness
Time frame: Change from baseline at 3 months
Pulse wave velocity (m/s)
Arterial Stiffness
Time frame: Change from baseline at 3 months
Augmentation index (%)
Endothelial function
Time frame: Change from baseline at 3 months
Flow mediated dilation (% change)
6 secondary outcomes
Indices of metabolic health
Time frame: Change from baseline at 3 months
Cognitive function
Time frame: Change from baseline at 3 months
Cognitive function
Time frame: Change from baseline at 3 months
Cerebral Blood flow
Time frame: Change from baseline at 3 months
Cerebral Blood flow
Time frame: Change from baseline at 3 months
Exercise Capacity
Time frame: Change from baseline at 3 months
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 8 Apr 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montmorency tart cherry concentrate in people with Cardiometabolic Risk Factors and Cognitive Function, 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 8 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 8 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?
Blood pressure (time frame: Change from baseline at 3 months). The study lists 4 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 8 Apr 2021.