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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-12

Study Completion Date

2020-02-29

Brief Summary

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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).

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Detailed Description

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Conditions

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Cardiometabolic Risk Factors Cognitive Function Exercise Capacity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Montmorency tart cherry concentrate

Intervention Type DIETARY_SUPPLEMENT

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)

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo beverage matched for calorie content and visual properties of the cherry concentrate

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo beverage matched for calorie content and visual properties of the cherry concentrate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes