Clinical trial NCT04021342: The Effect of Tart Cherry (Prunus Cerasus) Concentrate on Physiological and Cognitive Function
Official title: The Effect of Tart Cherry (Prunus Cerasus) Concentrate on Cardiometabolic Risk Factors, Exercise Capacity and Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Risk Factors
Cognitive Function
Exercise Capacity
Keywords: Tart cherry
Montmorency cherries
Prunus Cerasus
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Cherry Marketing Institute
First posted: 2019-07-16
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Blood pressure
timeFrame: Change from baseline at 3 months
measure: Arterial Stiffness
timeFrame: Change from baseline at 3 months
measure: Arterial Stiffness
timeFrame: Change from baseline at 3 months
measure: Endothelial function
timeFrame: Change from baseline at 3 months
Secondary outcomes:
measure: Indices of metabolic health
timeFrame: Change from baseline at 3 months
measure: Cognitive function
timeFrame: Change from baseline at 3 months
measure: Cognitive function
timeFrame: Change from baseline at 3 months
measure: Cerebral Blood flow
timeFrame: Change from baseline at 3 months
measure: Cerebral Blood flow
timeFrame: Change from baseline at 3 months
measure: Exercise Capacity
timeFrame: Change from baseline at 3 months
Other outcomes:
measure: Body composition
timeFrame: Change from baseline at 3 months
measure: Body composition
timeFrame: Change from baseline at 3 months
measure: Body composition
timeFrame: Change from baseline at 3 months
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria University
Study officials:
References: