Metabolic SyndromeNCT04177238
Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.
A study testing Fruit concentrate - either cherry or blueberry in people with Metabolic Syndrome, run by University of Central Lancashire at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Fruit concentrate - either cherry or blueberry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jan 2020to 5 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- 18 years of age and above
- Non-smoker
- BMI < 30
- Able to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Central Lancashire
Preston, Lancashire, PR4 0PE
About this study
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.
- Conditions
- Metabolic Syndrome
- Being tested
- Fruit concentrate - either cherry or blueberry
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit concentrate - either cherry or blueberryDietary supplement
Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Identical in taste and colour to the supplement juice, but with no anthocyanin content Receives: Dietary Supplement: Fruit concentrate - either cherry or blueberry |
| Cherry juice | Experimental | 30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day, Receives: Dietary Supplement: Fruit concentrate - either cherry or blueberry |
| Blueberry | Experimental | 30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day, Receives: Dietary Supplement: Fruit concentrate - either cherry or blueberry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Measured: Baseline
% bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
Measured: Baseline
% bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
Measured: 20 days
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Measured: Baseline
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Measured: 20 days
Resting metabolic rate
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Measured: Baseline
Resting metabolic rate
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Measured: 20 days
Resting utilization of carbohydrates
% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Measured: Baseline
Resting utilization of carbohydrates
% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Measured: 20 days
Resting utilization of fats
% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Measured: Baseline
Resting utilization of fats
% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20 days
Blood glucose
Capillary blood glucose - mmol/L
Measured: Baseline
Blood glucose
Capillary blood glucose - mmol/L
Measured: 20 days
Blood triglycerides
Capillary blood triglycerides - mmol/L
Measured: Baseline
Blood triglycerides
Capillary blood triglycerides - mmol/L
Measured: 20 days
Blood cholesterol (Total, HDL & LDL)
Capillary blood cholesterol - mmol/L
Measured: Baseline
Blood cholesterol (Total, HDL & LDL)
Capillary blood cholesterol - mmol/L
Measured: 20 days
Blood haemoglobin
Capillary blood haemoglobin - g/L
Measured: Baseline
Blood haemoglobin
Capillary blood haemoglobin - g/L
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start21 Jan 2020
- Primary completion5 Feb 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Sinclair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177238
- Sponsor's protocol ID
- Cherry/ blueberry concentrate
- Status last verified
- Oct 2022
- First submitted
- 21 Nov 2019
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sinclair J, Shadwell G, Dillon S, Allan R, Butters B, Bottoms L. Effects of Montmorency Tart Cherry and Blueberry Juice on Cardiometabolic Outcomes in Healthy Individuals: Protocol for a 3-Arm Placebo Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Sep 16;18(18):9759. doi: 10.3390/ijerph18189759.
PubMed 34574679
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.
- ClinicalTrials.gov ID
- NCT04177238
- Acronym / sponsor ID
- Cherry/ blueberry concentrate
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 5 Feb 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Fruit concentrate - either cherry or blueberryIdentical in taste and colour to the supplement juice, but with no anthocyanin content |
| Cherry juice | Experimental | Dietary Supplement: Fruit concentrate - either cherry or blueberry30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day, |
| Blueberry | Experimental | Dietary Supplement: Fruit concentrate - either cherry or blueberry30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day, |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy
- 18 years of age and above
- Non-smoker
- BMI < 30
- Able to give informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruit concentrate - either cherry or blueberryFruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/). | Dietary supplement | Blueberry, Cherry juice, Placebo |
Primary outcome
Blood pressure
Time frame: Baseline
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
% bodyfat
Time frame: Baseline
Participants percentage composition of fat - measured using bio-electrical impedance
% bodyfat
Time frame: 20 days
Participants percentage composition of fat - measured using bio-electrical impedance
Waist to hip ratio
Time frame: Baseline
Ratio of waist to hip circumference - measured using anthropocentric tape
Waist to hip ratio
Time frame: 20 days
Ratio of waist to hip circumference - measured using anthropocentric tape
Resting metabolic rate
Time frame: Baseline
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Resting metabolic rate
Time frame: 20 days
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of carbohydrates
Time frame: Baseline
% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of carbohydrates
Time frame: 20 days
% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of fats
Time frame: Baseline
% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of fats
Time frame: 20 days
% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
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.
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.
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.
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.
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.
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.
Blood glucose
Time frame: Baseline
Capillary blood glucose - mmol/L
Blood glucose
Time frame: 20 days
Capillary blood glucose - mmol/L
Blood triglycerides
Time frame: Baseline
Capillary blood triglycerides - mmol/L
Blood triglycerides
Time frame: 20 days
Capillary blood triglycerides - mmol/L
Blood cholesterol (Total, HDL & LDL)
Time frame: Baseline
Capillary blood cholesterol - mmol/L
Blood cholesterol (Total, HDL & LDL)
Time frame: 20 days
Capillary blood cholesterol - mmol/L
Blood haemoglobin
Time frame: Baseline
Capillary blood haemoglobin - g/L
Blood haemoglobin
Time frame: 20 days
Capillary blood haemoglobin - g/L
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 34574679Sinclair J, Shadwell G, Dillon S, Allan R, Butters B, Bottoms L. Effects of Montmorency Tart Cherry and Blueberry Juice on Cardiometabolic Outcomes in Healthy Individuals: Protocol for a 3-Arm Placebo Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Sep 16;18(18):9759. doi: 10.3390/ijerph18189759.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit concentrate - either cherry or blueberry in people with Metabolic Syndrome, run by University of Central Lancashire at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Baseline). The study lists 37 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04177238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.