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

Northumbria University

Status: Completed

Conditions: Cognitive Function; Cardiometabolic Risk Factors; Exercise Capacity

Treatments: Dietary Supplement: Montmorency tart cherry concentrate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04021342

4240

Details and patient eligibility

About

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).

Enrollment: 56 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups, including a placebo group

Montmorency tart cherry concentrate

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: Montmorency tart cherry concentrate

Isocaloric cherry flavoured placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo