Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Fruit concentrate - either cherry or blueberry

• Registration Number: NCT04177238
• Lead Sponsor: University of Central Lancashire

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-26
• Study Start: 2020-01-21
• Primary Completion: 2022-02-05
• Study Completion: 2022-08-05
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cherry juice	Fruit concentrate - either cherry or blueberry	30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day,
Blueberry	Fruit concentrate - either cherry or blueberry	30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day,
Placebo	Fruit concentrate - either cherry or blueberry	Identical in taste and colour to the supplement juice, but with no anthocyanin content

Primary Outcome Measures

Name	Time	Method
Resting metabolic rate	20 days	Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of carbohydrates	20 days	% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Blood glucose	20 days	Capillary blood glucose - mmol/L
Resting utilization of fats	20 days	% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Coop-Wonka chart	20 days	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.
Blood pressure	Baseline	Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Waist to hip ratio	20 days	Ratio of waist to hip circumference - measured using anthropocentric tape
Low-moderate intensity activity utilization of carbohydrates	20 days	% contribution of carbohydrates to calorie expenditure - during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
State Trait Anxiety Inventory	20 days	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.
Insomnia Severity Index	20 days	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.
Pittsburgh Sleep Quality Index	20 days	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.
Beck Depression Inventory	20 days	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.
% bodyfat	20 days	Participants percentage composition of fat - measured using bio-electrical impedance
Low-moderate intensity activity calories expended	20 days	Estimated calorie usage (Kcal) during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Low-moderate intensity activity utilization of fats	20 days	% contribution of fats to calorie expenditure - during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Blood cholesterol (Total, HDL & LDL)	20 days	Capillary blood cholesterol - mmol/L
Blood triglycerides	20 days	Capillary blood triglycerides - mmol/L
Blood haemoglobin	20 days	Capillary blood haemoglobin - g/L
Epworth Sleepiness Scale	20 days	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.

Trial Locations

Locations (1)

University of Central Lancashire; 🇬🇧 Preston, Lancashire, United Kingdom