The Effect of Tart Cherry (Prunus Cerasus) Concentrate on Physiological and Cognitive Function
- Conditions
- Cognitive FunctionExercise CapacityCardiometabolic Risk Factors
- Interventions
- Dietary Supplement: Montmorency tart cherry concentrateDietary Supplement: Placebo
- Registration Number
- NCT04021342
- Lead Sponsor
- Northumbria University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Montmorency tart cherry concentrate 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). Isocaloric cherry flavoured placebo 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.
- Primary Outcome Measures
Name Time Method Arterial Stiffness Change from baseline at 3 months Augmentation index (%)
Blood pressure Change from baseline at 3 months Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg)
Endothelial function Change from baseline at 3 months Flow mediated dilation (% change)
- Secondary Outcome Measures
Name Time Method Cognitive function Change from baseline at 3 months Computerized cognitive function assessment reaction time (m/s)
Cerebral Blood flow Change from baseline at 3 months Deoxygenated heamoglobin (deoxyhb)
Indices of metabolic health Change from baseline at 3 months glucose (mmol/L) triglycerides (mmol/L) LDL cholesterol (mmol/L) HDL cholesterol (mmol/L)
Exercise Capacity Change from baseline at 3 months Estimated aerobic exercise capacity (VO2max) measured by a submaximal cycling test
Trial Locations
- Locations (1)
Northumbria University
🇬🇧Newcastle Upon Tyne, United Kingdom