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Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.

Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04177238
Enrollment
45
Registered
2019-11-26
Start date
2020-01-21
Completion date
2022-08-05
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

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.

Interventions

DIETARY_SUPPLEMENTFruit concentrate - either cherry or blueberry

Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).

Sponsors

University of Central Lancashire
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressureBaselineSystolic and diastolic blood pressure - measured using a digital blood pressure monitor
% bodyfatBaselineParticipants percentage composition of fat - measured using bio-electrical impedance
Waist to hip ratioBaselineRatio of waist to hip circumference - measured using anthropocentric tape
Resting metabolic rateBaselineEstimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of carbohydratesBaseline% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of fatsBaseline% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Low-moderate intensity activity calories expendedBaselineEstimated calorie usage (Kcal) during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Low-moderate intensity activity utilization of fatsBaseline% contribution of fats to calorie expenditure - during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Low-moderate intensity activity utilization of carbohydratesBaseline% contribution of carbohydrates to calorie expenditure - during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Blood glucoseBaselineCapillary blood glucose - mmol/L
Blood triglyceridesBaselineCapillary blood triglycerides - mmol/L
Blood cholesterol (Total, HDL & LDL)BaselineCapillary blood cholesterol - mmol/L
Blood haemoglobinBaselineCapillary blood haemoglobin - g/L
Coop-Wonka chartBaselinePsychological 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.
Beck Depression InventoryBaselinePsychological 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.
State Trait Anxiety InventoryBaselinePsychological 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 IndexBaselineSleep 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 IndexBaselineSleep 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.
Epworth Sleepiness ScaleBaselineSleep 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026