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

Not Applicable

Completed

• Conditions: Cognitive Function; Exercise Capacity; Cardiometabolic Risk Factors

• 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

Study Timeline

• Study Start: 2018-10-12
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-16
• Primary Completion: 2019-11-29
• Study Completion: 2020-02-29
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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