NCT04177238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 21, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

November 21, 2019

Last Update Submit

October 31, 2022

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (37)

  • Blood pressure

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

    Baseline

  • % bodyfat

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

    Baseline

  • % bodyfat

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

    20 days

  • Waist to hip ratio

    Ratio of waist to hip circumference - measured using anthropocentric tape

    Baseline

  • Waist to hip ratio

    Ratio of waist to hip circumference - measured using anthropocentric tape

    20 days

  • Resting metabolic rate

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

    Baseline

  • Resting metabolic rate

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

    20 days

  • Resting utilization of carbohydrates

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

    Baseline

  • Resting utilization of carbohydrates

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

    20 days

  • Resting utilization of fats

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

    Baseline

  • Resting utilization of fats

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

    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.

    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.

    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.

    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.

    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.

    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.

    20 days

  • Blood glucose

    Capillary blood glucose - mmol/L

    Baseline

  • Blood glucose

    Capillary blood glucose - mmol/L

    20 days

  • Blood triglycerides

    Capillary blood triglycerides - mmol/L

    Baseline

  • Blood triglycerides

    Capillary blood triglycerides - mmol/L

    20 days

  • Blood cholesterol (Total, HDL & LDL)

    Capillary blood cholesterol - mmol/L

    Baseline

  • Blood cholesterol (Total, HDL & LDL)

    Capillary blood cholesterol - mmol/L

    20 days

  • Blood haemoglobin

    Capillary blood haemoglobin - g/L

    Baseline

  • Blood haemoglobin

    Capillary blood haemoglobin - g/L

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    20 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Identical in taste and colour to the supplement juice, but with no anthocyanin content

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,

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,

Dietary Supplement: Fruit concentrate - either cherry or blueberry

Interventions

Fruit concentrate - either cherry or blueberryDIETARY_SUPPLEMENT

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

BlueberryCherry juicePlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Lancashire

Preston, Lancashire, PR4 0PE, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34574679DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

blueberry extract

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator - Professor of Sport, Exercise & Nutritional Sciences

Study Record Dates

First Submitted

November 21, 2019

First Posted

November 26, 2019

Study Start

January 21, 2020

Primary Completion

February 5, 2022

Study Completion

August 5, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

GB(1)