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

NCT04021342 | Completed

• 1 other identifier: 4240
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiometabolic Risk Factors; Cognitive Function; Exercise Capacity

Keywords

Tart cherry; Montmorency cherries; Prunus Cerasus

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Indices of metabolic health

  Change from baseline at 3 months

• Cognitive function

  Change from baseline at 3 months

• Cognitive function

  Change from baseline at 3 months

• Cerebral Blood flow

  Change from baseline at 3 months

• Cerebral Blood flow

  Change from baseline at 3 months

Other Outcomes (3)

• Body composition

  Change from baseline at 3 months

• Body composition

  Change from baseline at 3 months

• Body composition

  Change from baseline at 3 months

Study Arms (2)

Montmorency tart cherry concentrate

ACTIVE COMPARATOR

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

Isocaloric cherry flavoured placebo

PLACEBO COMPARATOR

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

Interventions

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)

Montmorency tart cherry concentrate

Placebo DIETARY_SUPPLEMENT

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

Isocaloric cherry flavoured placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• Cherry Marketing Institute: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, NE18ST, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: July 16, 2019
• Study Start: October 12, 2018
• Primary Completion: November 29, 2019
• Study Completion: February 29, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)