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

Study Overview
=================
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).

Official Title
-----------------
The Effect of Tart Cherry (Prunus Cerasus) Concentrate on Cardiometabolic Risk Factors, Exercise Capacity and Cognitive Function

Conditions
-----------------
Cardiometabolic Risk Factors, Cognitive Function, Exercise Capacity

Intervention / Treatment
-----------------
* Dietary Supplement: Montmorency tart cherry concentrate
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Montmorency tart cherry concentrate<br>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<br>* 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)<br>|
| Placebo Comparator: Isocaloric cherry flavoured placebo<br>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<br>* Placebo beverage matched for calorie content and visual properties of the cherry concentrate<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg) | Change from baseline at 3 months | 
| Arterial Stiffness | Pulse wave velocity (m/s) | Change from baseline at 3 months | 
| Arterial Stiffness | Augmentation index (%) | Change from baseline at 3 months | 
| Endothelial function | Flow mediated dilation (% change) | Change from baseline at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indices of metabolic health | glucose (mmol/L) triglycerides (mmol/L) LDL cholesterol (mmol/L) HDL cholesterol (mmol/L) | Change from baseline at 3 months | 
| Cognitive function | Computerized cognitive function assessment percentage accuracy (%) | Change from baseline at 3 months | 
| Cognitive function | Computerized cognitive function assessment reaction time (m/s) | Change from baseline at 3 months | 
| Cerebral Blood flow | Oxygenated heamoglobin (Oxyhb) | Change from baseline at 3 months | 
| Cerebral Blood flow | Deoxygenated heamoglobin (deoxyhb) | Change from baseline at 3 months | 
| Exercise Capacity | Estimated aerobic exercise capacity (VO2max) measured by a submaximal cycling test | Change from baseline at 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tart cherry, Montmorency cherries, Prunus Cerasus