Acute Cardio-metabolic Responses to Montmorency Tart Cherry Supplementation in Metabolic Syndrome Patients
Primary Purpose
Metabolic Syndrome, Insulin Resistance, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Montmorency Tart Cherry Capsules
Montmorency Tart Cherry Juice
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring Montmorency Tart Cherry, Anthocyanins, Polyphenols, Metabolic Syndrome, Insulin Resistance, Hypertension, Lipid Profile
Eligibility Criteria
Inclusion Criteria:
- Non-smoker,
Meet 3 of 5 criteria for Metabolic Syndrome based on National Cholesterol Education Program-Adult Treatment Panel III guidelines:
- Waist Circumference: >102cm (men), >88cm (women)
- Fasting Serum Triglycerides: ≥1.69 mmol.L-1
- Fasting High Density Lipoprotein: <1.03 mmol.L-1 (men), <1.29 mmol.L-1 (women)
- Blood Pressure: ≥130 mmHg SBP or ≥85 mmHg DBP
- Fasting Plasma Glucose: ≥6.1 mmol.L-1
Exclusion Criteria:
- Current or previous history of gastrointestinal, cardiovascular, hepatic or renal disease, currently diagnosed with diabetes or uncontrolled hypertension (≥160/100 mmHg), allergy to maltodextrin or specific fruit products and those currently taking medication (such as steroids, NSAIDs, antibiotics, antihypertensive, hypoglycaemic, lipid-lowering drugs) or currently using any nutritional or antioxidant supplement. Heavy alcohol consumption (>14 units per week).
Sites / Locations
- University of Hertfordshire
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo Drink
Montmorency Tart Cherry Capsules
Montmorency Tart Cherry Juice
Arm Description
Placebo drink attempted to match for total energy, appearance and taste of Montmorency tart cherry juice.
10 capsules consumed to match total anthocyanin content to Montmorency tart cherry juice.
Single-bolus of Montmorency tart cherry juice (130 mL)
Outcomes
Primary Outcome Measures
Change in Fasting Insulin
Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)
Change in Fasting Glucose
Change in Systolic and Diastolic Blood Pressure
Secondary Outcome Measures
Change in Augmentation Index
Measure of arterial stiffness and central blood pressures
Change in Aortic Systolic and Diastolic Pressure
Measure of arterial stiffness and central blood pressures
Change in Augmentation Pressure
Measure of arterial stiffness and central blood pressures
Change in Cardiac Output
Beat-to-beat resting cardiac haemodynamics (cardiac output, mean arterial pressure, strove volume, total peripheral resistance, heart rate)
Change in Stroke Volume
Beat-to-beat resting cardiac haemodynamics
Change in Heart Rate
Beat-to-beat resting cardiac haemodynamics
Change in Mean Arterial Pressure
Beat-to-beat resting cardiac haemodynamics
Change in Total Peripheral Resistance
Beat-to-beat resting cardiac haemodynamics
Change in Resting Energy Expenditure
Measured from indirect calorimetry
Change in Respiratory Quotient
Measured from indirect calorimetry
Full Information
NCT ID
NCT03615885
First Posted
July 20, 2018
Last Updated
July 30, 2018
Sponsor
University of Hertfordshire
Collaborators
Heart UK
1. Study Identification
Unique Protocol Identification Number
NCT03615885
Brief Title
Acute Cardio-metabolic Responses to Montmorency Tart Cherry Supplementation in Metabolic Syndrome Patients
Official Title
Acute Cardio-metabolic Responses to Different Forms of Montmorency Tart Cherry Supplementation in Humans With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
October 15, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hertfordshire
Collaborators
Heart UK
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present study examined the effect of Montmorency tart cherry juice and capsules on functional and blood-based cardio-metabolic markers in humans with Metabolic Syndrome. Participants received a single bolus of Montmorency tart cherry juice, Montmorency tart cherry capsules and placebo in a random, crossover trial. Outcome variables were measured immediately pre- and up to 5 hours post-bolus. It was hypothesised that Montmorency tart cherry juice and capsules would improve cardio-metabolic markers. Furthermore, it was hypothesised that Montmorency tart cherry capsules would be more beneficial than Montmorency tart cherry juice due to increased bioavailability of phytochemicals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Insulin Resistance, Hypertension
Keywords
Montmorency Tart Cherry, Anthocyanins, Polyphenols, Metabolic Syndrome, Insulin Resistance, Hypertension, Lipid Profile
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Drink
Arm Type
Placebo Comparator
Arm Description
Placebo drink attempted to match for total energy, appearance and taste of Montmorency tart cherry juice.
Arm Title
Montmorency Tart Cherry Capsules
Arm Type
Experimental
Arm Description
10 capsules consumed to match total anthocyanin content to Montmorency tart cherry juice.
Arm Title
Montmorency Tart Cherry Juice
Arm Type
Experimental
Arm Description
Single-bolus of Montmorency tart cherry juice (130 mL)
Intervention Type
Dietary Supplement
Intervention Name(s)
Montmorency Tart Cherry Capsules
Intervention Description
Capsules are made from 100% natural, tart Montmorency cherries. Carefully prepared Montmorency cherry skins are freeze-dried and milled into a fine powder to protect the cherry phytonutrients and optimise absorbtion. This powder is then encapsulated into a 100% vegetarian shell.
Intervention Type
Dietary Supplement
Intervention Name(s)
Montmorency Tart Cherry Juice
Intervention Description
100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water.
Concentrate contains no sweeteners, preservatives, flavourings or added sugar.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
130ml serving
Placebo composition: Water (100ml), Cherry Cordial Concentrate (30ml), Citric Acid (1.5g), Maltodextrin (24.75g), Black Food Colouring (2ml).
Primary Outcome Measure Information:
Title
Change in Fasting Insulin
Time Frame
Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Title
Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)
Time Frame
Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Title
Change in Fasting Glucose
Time Frame
Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Title
Change in Systolic and Diastolic Blood Pressure
Time Frame
Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary Outcome Measure Information:
Title
Change in Augmentation Index
Description
Measure of arterial stiffness and central blood pressures
Time Frame
Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Title
Change in Aortic Systolic and Diastolic Pressure
Description
Measure of arterial stiffness and central blood pressures
Time Frame
Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Title
Change in Augmentation Pressure
Description
Measure of arterial stiffness and central blood pressures
Time Frame
Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Title
Change in Cardiac Output
Description
Beat-to-beat resting cardiac haemodynamics (cardiac output, mean arterial pressure, strove volume, total peripheral resistance, heart rate)
Time Frame
Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Title
Change in Stroke Volume
Description
Beat-to-beat resting cardiac haemodynamics
Time Frame
Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Title
Change in Heart Rate
Description
Beat-to-beat resting cardiac haemodynamics
Time Frame
Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Title
Change in Mean Arterial Pressure
Description
Beat-to-beat resting cardiac haemodynamics
Time Frame
Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Title
Change in Total Peripheral Resistance
Description
Beat-to-beat resting cardiac haemodynamics
Time Frame
Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Title
Change in Resting Energy Expenditure
Description
Measured from indirect calorimetry
Time Frame
Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Title
Change in Respiratory Quotient
Description
Measured from indirect calorimetry
Time Frame
Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-smoker,
Meet 3 of 5 criteria for Metabolic Syndrome based on National Cholesterol Education Program-Adult Treatment Panel III guidelines:
Waist Circumference: >102cm (men), >88cm (women)
Fasting Serum Triglycerides: ≥1.69 mmol.L-1
Fasting High Density Lipoprotein: <1.03 mmol.L-1 (men), <1.29 mmol.L-1 (women)
Blood Pressure: ≥130 mmHg SBP or ≥85 mmHg DBP
Fasting Plasma Glucose: ≥6.1 mmol.L-1
Exclusion Criteria:
Current or previous history of gastrointestinal, cardiovascular, hepatic or renal disease, currently diagnosed with diabetes or uncontrolled hypertension (≥160/100 mmHg), allergy to maltodextrin or specific fruit products and those currently taking medication (such as steroids, NSAIDs, antibiotics, antihypertensive, hypoglycaemic, lipid-lowering drugs) or currently using any nutritional or antioxidant supplement. Heavy alcohol consumption (>14 units per week).
Facility Information:
Facility Name
University of Hertfordshire
City
Hatfield
ZIP/Postal Code
AL10 9AB
Country
United Kingdom
12. IPD Sharing Statement
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Acute Cardio-metabolic Responses to Montmorency Tart Cherry Supplementation in Metabolic Syndrome Patients
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