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OpenTrials
Completed

NCT Number: NCT04021342

The Effect of Tart Cherry (Prunus Cerasus) Concentrate on Physiological 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).

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Key information

Conditions

Cardiometabolic Risk Factors Cognitive Function Exercise Capacity

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria University

Newcastle upon Tyne, NE18ST, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montmorency tart cherry concentrate

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)

Placebo

Dietary Supplement

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

Primary outcomes

  1. Blood pressure

    Time frame: Change from baseline at 3 months

    Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg)

  2. Arterial Stiffness

    Time frame: Change from baseline at 3 months

    Pulse wave velocity (m/s)

  3. Arterial Stiffness

    Time frame: Change from baseline at 3 months

    Augmentation index (%)

  4. Endothelial function

    Time frame: Change from baseline at 3 months

    Flow mediated dilation (% change)

Secondary outcomes

  1. Indices of metabolic health

    Time frame: Change from baseline at 3 months

    glucose (mmol/L) triglycerides (mmol/L) LDL cholesterol (mmol/L) HDL cholesterol (mmol/L)

  2. Cognitive function

    Time frame: Change from baseline at 3 months

    Computerized cognitive function assessment percentage accuracy (%)

  3. Cognitive function

    Time frame: Change from baseline at 3 months

    Computerized cognitive function assessment reaction time (m/s)

  4. Cerebral Blood flow

    Time frame: Change from baseline at 3 months

    Oxygenated heamoglobin (Oxyhb)

  5. Cerebral Blood flow

    Time frame: Change from baseline at 3 months

    Deoxygenated heamoglobin (deoxyhb)

  6. Exercise Capacity

    Time frame: Change from baseline at 3 months

    Estimated aerobic exercise capacity (VO2max) measured by a submaximal cycling test

Other outcomes

  1. Body composition

    Time frame: Change from baseline at 3 months

    Fat mass (g) Lean mass (g)

  2. Body composition

    Time frame: Change from baseline at 3 months

    Fat percentage (%)

  3. Body composition

    Time frame: Change from baseline at 3 months

    Android/gynoid ratio

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • Cherry Marketing Institute

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 16, 2019
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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