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

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

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).

Study Overview

• Status: Completed
• Conditions: Cognitive Function; Exercise Capacity; Cardiometabolic Risk Factors
• Intervention / Treatment: Dietary supplement: Montmorency tart cherry concentrate; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle Upon Tyne, United Kingdom, NE18ST
    • Northumbria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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).	Dietary supplement: Montmorency 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)
PLACEBO_COMPARATOR: Isocaloric cherry flavoured 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.	Dietary supplement: Placebo; Placebo beverage matched for calorie content and visual properties of the cherry concentrate

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Fat mass (g) Lean mass (g)	Change from baseline at 3 months
Body composition	Fat percentage (%)	Change from baseline at 3 months
Body composition	Android/gynoid ratio	Change from baseline at 3 months

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: Cherry Marketing Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 12, 2018
• Primary Completion (ACTUAL): November 29, 2019
• Study Completion (ACTUAL): February 29, 2020

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (ACTUAL): July 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Tart cherry; Montmorency cherries; Prunus Cerasus
• Other Study ID Numbers: 4240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No