Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Fruit concentrate - either cherry or blueberry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Identical in taste and colour to the supplement juice, but with no anthocyanin content | Dietary Supplement: Fruit concentrate - either cherry or blueberry<br>* Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).<br>|
| Experimental: Cherry juice<br>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<br>* Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).<br>|
| Experimental: Blueberry<br>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<br>* Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic and diastolic blood pressure - measured using a digital blood pressure monitor | Baseline | 
| % 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 | 
| 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 | 
| 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 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 | 
| 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 | 
| 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 | 
| Blood haemoglobin | Capillary blood haemoglobin - g/L | Baseline | 
| Blood haemoglobin | Capillary blood haemoglobin - g/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 |