Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.

Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. Anthocyanins, found in high quantities in both tart cherries and blueberries are powerful antioxidants, that are potentially capable of improving cardiometabolic dysfunction. However, to date, no research has explored the cardiometabolic responses to tart cherry and blueberry supplementation.

Therefore, the primary purpose of the proposed investigation is to test the ability of oral tart cherry and blueberry supplementation to improve cardiometabolic parameters in healthy individuals.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Fruit concentrate - either cherry or blueberry

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR4 0PE
      • University of Central Lancashire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy
• 18 years of age and above
• Non-smoker
• BMI < 30
• Able to give informed consent

Exclusion Criteria:

• Pregnancy
• Diabetes or any other metabolic/ uncontrolled hypertensive conditions
• Food allergies to cherries or blueberries
• Habitual consumption of blueberries/ cherries and/or blueberry/ cherry products
• Not regularly taking medication or antioxidant supplements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Identical in taste and colour to the supplement juice, but with no anthocyanin content	Dietary supplement: Fruit concentrate - either cherry or blueberry; Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).
Experimental: Cherry juice; 30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day,	Dietary supplement: Fruit concentrate - either cherry or blueberry; Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).
Experimental: Blueberry; 30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day,	Dietary supplement: Fruit concentrate - either cherry or blueberry; Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Systolic and diastolic blood pressure - measured using a digital blood pressure monitor	Baseline
Waist to hip ratio	Ratio of waist to hip circumference - measured using anthropocentric tape	Baseline
Waist to hip ratio	Ratio of waist to hip circumference - measured using anthropocentric tape	20 days
Resting metabolic rate	Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.	Baseline
Resting metabolic rate	Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.	20 days
Blood glucose	Capillary blood glucose - mmol/L	Baseline
Blood glucose	Capillary blood glucose - mmol/L	20 days
Blood triglycerides	Capillary blood triglycerides - mmol/L	Baseline
Blood triglycerides	Capillary blood triglycerides - mmol/L	20 days
Blood cholesterol (Total, HDL & LDL)	Capillary blood cholesterol - mmol/L	Baseline
Blood cholesterol (Total, HDL & LDL)	Capillary blood cholesterol - mmol/L	20 days
Coop-Wonka chart	Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.	Baseline
Coop-Wonka chart	Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.	20 days
Beck Depression Inventory	Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.	Baseline
Beck Depression Inventory	Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.	20 days
State Trait Anxiety Inventory	Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.	Baseline
State Trait Anxiety Inventory	Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.	20 days
Insomnia Severity Index	Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.	Baseline
Insomnia Severity Index	Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.	20 days
Pittsburgh Sleep Quality Index	Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.	Baseline
Pittsburgh Sleep Quality Index	Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.	20 days
Epworth Sleepiness Scale	Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.	Baseline
Epworth Sleepiness Scale	Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.	20 days
Low-moderate intensity activity calories expended	Estimated calorie usage (Kcal) during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.	Baseline
Low-moderate intensity activity calories expended	Estimated calorie usage (Kcal) during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.	20 days
Blood haemoglobin	Capillary blood haemoglobin - g/L	Baseline
Blood haemoglobin	Capillary blood haemoglobin - g/L	20 days
% bodyfat	Participants percentage composition of fat - measured using bio-electrical impedance	Baseline
% bodyfat	Participants percentage composition of fat - measured using bio-electrical impedance	20 days
Resting utilization of carbohydrates	% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.	Baseline
Resting utilization of carbohydrates	% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.	20 days
Resting utilization of fats	% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.	Baseline
Resting utilization of fats	% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.	20 days
Low-moderate intensity activity utilization of fats	% contribution of fats to calorie expenditure - during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.	Baseline
Low-moderate intensity activity utilization of fats	% contribution of fats to calorie expenditure - during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.	20 days
Low-moderate intensity activity utilization of carbohydrates	% contribution of carbohydrates to calorie expenditure - during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.	Baseline
Low-moderate intensity activity utilization of carbohydrates	% contribution of carbohydrates to calorie expenditure - during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.	20 days

Collaborators and Investigators

• Sponsor: University of Central Lancashire

Publications and helpful links

General Publications

• Sinclair J, Shadwell G, Dillon S, Allan R, Butters B, Bottoms L. Effects of Montmorency Tart Cherry and Blueberry Juice on Cardiometabolic Outcomes in Healthy Individuals: Protocol for a 3-Arm Placebo Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Sep 16;18(18):9759. doi: 10.3390/ijerph18189759.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Actual): February 5, 2022
• Study Completion (Actual): August 5, 2022

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: Cherry/ blueberry concentrate

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No