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

Cognitive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04021342
• Other study ID #: 4240
• Status: Completed
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: February 29, 2020

Study information

• Verified date: April 2021
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 29, 2020
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Risk Factors
• Cognitive Function
• Exercise Capacity

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle Upon Tyne

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Cherry Marketing Institute

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body composition	Fat mass (g) Lean mass (g)	Change from baseline at 3 months
Other	Body composition	Fat percentage (%)	Change from baseline at 3 months
Other	Body composition	Android/gynoid ratio	Change from baseline at 3 months
Primary	Blood pressure	Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg)	Change from baseline at 3 months
Primary	Arterial Stiffness	Pulse wave velocity (m/s)	Change from baseline at 3 months
Primary	Arterial Stiffness	Augmentation index (%)	Change from baseline at 3 months
Primary	Endothelial function	Flow mediated dilation (% change)	Change from baseline at 3 months
Secondary	Indices of metabolic health	glucose (mmol/L) triglycerides (mmol/L) LDL cholesterol (mmol/L) HDL cholesterol (mmol/L)	Change from baseline at 3 months
Secondary	Cognitive function	Computerized cognitive function assessment percentage accuracy (%)	Change from baseline at 3 months
Secondary	Cognitive function	Computerized cognitive function assessment reaction time (m/s)	Change from baseline at 3 months
Secondary	Cerebral Blood flow	Oxygenated heamoglobin (Oxyhb)	Change from baseline at 3 months
Secondary	Cerebral Blood flow	Deoxygenated heamoglobin (deoxyhb)	Change from baseline at 3 months
Secondary	Exercise Capacity	Estimated aerobic exercise capacity (VO2max) measured by a submaximal cycling test	Change from baseline at 3 months