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Completed

NCT Number: NCT04177238

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Lancashire

Preston, Lancashire, PR4 0PE, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fruit concentrate - either cherry or blueberry

Dietary Supplement

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

Primary outcomes

  1. Blood pressure

    Time frame: Baseline

    Systolic and diastolic blood pressure - measured using a digital blood pressure monitor

  2. % bodyfat

    Time frame: Baseline

    Participants percentage composition of fat - measured using bio-electrical impedance

  3. % bodyfat

    Time frame: 20 days

    Participants percentage composition of fat - measured using bio-electrical impedance

  4. Waist to hip ratio

    Time frame: Baseline

    Ratio of waist to hip circumference - measured using anthropocentric tape

  5. Waist to hip ratio

    Time frame: 20 days

    Ratio of waist to hip circumference - measured using anthropocentric tape

  6. Resting metabolic rate

    Time frame: Baseline

    Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.

  7. Resting metabolic rate

    Time frame: 20 days

    Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.

  8. Resting utilization of carbohydrates

    Time frame: Baseline

    % contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.

  9. Resting utilization of carbohydrates

    Time frame: 20 days

    % contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.

  10. Resting utilization of fats

    Time frame: Baseline

    % contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.

  11. Resting utilization of fats

    Time frame: 20 days

    % contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.

  12. Low-moderate intensity activity calories expended

    Time frame: Baseline

    Estimated calorie usage (Kcal) during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.

  13. Low-moderate intensity activity calories expended

    Time frame: 20 days

    Estimated calorie usage (Kcal) during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.

  14. Low-moderate intensity activity utilization of fats

    Time frame: Baseline

    % contribution of fats to calorie expenditure - during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.

  15. Low-moderate intensity activity utilization of fats

    Time frame: 20 days

    % contribution of fats to calorie expenditure - during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.

  16. Low-moderate intensity activity utilization of carbohydrates

    Time frame: Baseline

    % contribution of carbohydrates to calorie expenditure - during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.

  17. Low-moderate intensity activity utilization of carbohydrates

    Time frame: 20 days

    % contribution of carbohydrates to calorie expenditure - during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.

  18. Blood glucose

    Time frame: Baseline

    Capillary blood glucose - mmol/L

  19. Blood glucose

    Time frame: 20 days

    Capillary blood glucose - mmol/L

  20. Blood triglycerides

    Time frame: Baseline

    Capillary blood triglycerides - mmol/L

  21. Blood triglycerides

    Time frame: 20 days

    Capillary blood triglycerides - mmol/L

  22. Blood cholesterol (Total, HDL & LDL)

    Time frame: Baseline

    Capillary blood cholesterol - mmol/L

  23. Blood cholesterol (Total, HDL & LDL)

    Time frame: 20 days

    Capillary blood cholesterol - mmol/L

  24. Blood haemoglobin

    Time frame: Baseline

    Capillary blood haemoglobin - g/L

  25. Blood haemoglobin

    Time frame: 20 days

    Capillary blood haemoglobin - g/L

  26. Coop-Wonka chart

    Time frame: Baseline

    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.

  27. Coop-Wonka chart

    Time frame: 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.

  28. Beck Depression Inventory

    Time frame: Baseline

    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.

  29. Beck Depression Inventory

    Time frame: 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.

  30. State Trait Anxiety Inventory

    Time frame: Baseline

    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.

  31. State Trait Anxiety Inventory

    Time frame: 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.

  32. Insomnia Severity Index

    Time frame: Baseline

    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.

  33. Insomnia Severity Index

    Time frame: 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.

  34. Pittsburgh Sleep Quality Index

    Time frame: Baseline

    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.

  35. Pittsburgh Sleep Quality Index

    Time frame: 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.

  36. Epworth Sleepiness Scale

    Time frame: Baseline

    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.

  37. Epworth Sleepiness Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Central Lancashire

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2019
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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