Cardiometabolic Risk Factors, Cognitive Function, Exercise Capacity
Conditions
Keywords
Tart cherry, Montmorency cherries, Prunus Cerasus
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).
Interventions
DIETARY_SUPPLEMENTMontmorency 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)
DIETARY_SUPPLEMENTPlacebo
Placebo beverage matched for calorie content and visual properties of the cherry concentrate
Sponsors
Cherry Marketing Institute
Northumbria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function | Change from baseline at 3 months | Flow mediated dilation (% change) |
| Blood pressure | Change from baseline at 3 months | Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg) |
| Arterial Stiffness | Change from baseline at 3 months | Pulse wave velocity (m/s) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Blood flow | Change from baseline at 3 months | Oxygenated heamoglobin (Oxyhb) |
| Exercise Capacity | Change from baseline at 3 months | Estimated aerobic exercise capacity (VO2max) measured by a submaximal cycling test |
| Indices of metabolic health | Change from baseline at 3 months | glucose (mmol/L) triglycerides (mmol/L) LDL cholesterol (mmol/L) HDL cholesterol (mmol/L) |
| Cognitive function | Change from baseline at 3 months | Computerized cognitive function assessment percentage accuracy (%) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body composition | Change from baseline at 3 months | Fat mass (g) Lean mass (g) |
Countries
United Kingdom
Outcome results
None listed