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The Effect of Tart Cherry (Prunus Cerasus) Concentrate on Physiological and Cognitive Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04021342
Recruitment Status : Completed
First Posted : July 16, 2019
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Cherry Marketing Institute
Information provided by (Responsible Party):
Northumbria University

Study Description
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Brief 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. 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).

Condition or disease Intervention/treatment Phase
Cardiometabolic Risk Factors Cognitive Function Exercise Capacity Dietary Supplement: Montmorency tart cherry concentrate Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The treatment drink (tart cherry concentrate) and placebo are matched for colour and packed in identical plastic containers. The assigned beverages are packed and given to the participants by an independent researcher not involved in the study.
Primary Purpose: Prevention
Official Title: The Effect of Tart Cherry (Prunus Cerasus) Concentrate on Cardiometabolic Risk Factors, Exercise Capacity and Cognitive Function
Actual Study Start Date : October 12, 2018
Actual Primary Completion Date : November 29, 2019
Actual Study Completion Date : February 29, 2020
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Montmorency tart cherry concentrate
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).
 Dietary Supplement: Montmorency tart cherry concentrate
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)
Placebo Comparator: Isocaloric cherry flavoured placebo
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.
 Dietary Supplement: Placebo
Placebo beverage matched for calorie content and visual properties of the cherry concentrate


Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure [ Time Frame: Change from baseline at 3 months ]
    Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg)

  2. Arterial Stiffness [ Time Frame: Change from baseline at 3 months ]
    Pulse wave velocity (m/s)

  3. Arterial Stiffness [ Time Frame: Change from baseline at 3 months ]
    Augmentation index (%)

  4. Endothelial function [ Time Frame: Change from baseline at 3 months ]
    Flow mediated dilation (% change)


Secondary Outcome Measures :
  1. Indices of metabolic health [ Time Frame: Change from baseline at 3 months ]
    glucose (mmol/L) triglycerides (mmol/L) LDL cholesterol (mmol/L) HDL cholesterol (mmol/L)

  2. Cognitive function [ Time Frame: Change from baseline at 3 months ]
    Computerized cognitive function assessment percentage accuracy (%)

  3. Cognitive function [ Time Frame: Change from baseline at 3 months ]
    Computerized cognitive function assessment reaction time (m/s)

  4. Cerebral Blood flow [ Time Frame: Change from baseline at 3 months ]
    Oxygenated heamoglobin (Oxyhb)

  5. Cerebral Blood flow [ Time Frame: Change from baseline at 3 months ]
    Deoxygenated heamoglobin (deoxyhb)

  6. Exercise Capacity [ Time Frame: Change from baseline at 3 months ]
    Estimated aerobic exercise capacity (VO2max) measured by a submaximal cycling test


Other Outcome Measures:
  1. Body composition [ Time Frame: Change from baseline at 3 months ]
    Fat mass (g) Lean mass (g)

  2. Body composition [ Time Frame: Change from baseline at 3 months ]
    Fat percentage (%)

  3. Body composition [ Time Frame: Change from baseline at 3 months ]
    Android/gynoid ratio


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04021342


Locations
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United Kingdom
Northumbria University
Newcastle Upon Tyne, United Kingdom, NE18ST
Sponsors and Collaborators
Northumbria University
Cherry Marketing Institute
More Information
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Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT04021342    
Other Study ID Numbers: 4240
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northumbria University:
Tart cherry
Montmorency cherries
Prunus Cerasus