Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.

Metabolic Syndrome Clinical Trial

Official title:

Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177238
• Other study ID #: Cherry/ blueberry concentrate
• Status: Completed
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: August 5, 2022

Study information

• Verified date: October 2022
• Source: University of Central Lancashire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 5, 2022
• Est. primary completion date: February 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome

Intervention

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/).

Locations

Country	Name	City	State
United Kingdom	University of Central Lancashire	Preston	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Lancashire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Systolic and diastolic blood pressure - measured using a digital blood pressure monitor	Baseline
Primary	% bodyfat	Participants percentage composition of fat - measured using bio-electrical impedance	Baseline
Primary	% bodyfat	Participants percentage composition of fat - measured using bio-electrical impedance	20 days
Primary	Waist to hip ratio	Ratio of waist to hip circumference - measured using anthropocentric tape	Baseline
Primary	Waist to hip ratio	Ratio of waist to hip circumference - measured using anthropocentric tape	20 days
Primary	Resting metabolic rate	Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.	Baseline
Primary	Resting metabolic rate	Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.	20 days
Primary	Resting utilization of carbohydrates	% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.	Baseline
Primary	Resting utilization of carbohydrates	% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.	20 days
Primary	Resting utilization of fats	% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.	Baseline
Primary	Resting utilization of fats	% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.	20 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Blood glucose	Capillary blood glucose - mmol/L	Baseline
Primary	Blood glucose	Capillary blood glucose - mmol/L	20 days
Primary	Blood triglycerides	Capillary blood triglycerides - mmol/L	Baseline
Primary	Blood triglycerides	Capillary blood triglycerides - mmol/L	20 days
Primary	Blood cholesterol (Total, HDL & LDL)	Capillary blood cholesterol - mmol/L	Baseline
Primary	Blood cholesterol (Total, HDL & LDL)	Capillary blood cholesterol - mmol/L	20 days
Primary	Blood haemoglobin	Capillary blood haemoglobin - g/L	Baseline
Primary	Blood haemoglobin	Capillary blood haemoglobin - g/L	20 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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