Acute Cardio-metabolic Responses to Montmorency Tart Cherry Supplementation in Metabolic Syndrome Patients

Study Overview
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Brief Summary
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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.

Official Title
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Acute Cardio-metabolic Responses to Different Forms of Montmorency Tart Cherry Supplementation in Humans With Metabolic Syndrome

Conditions
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Metabolic Syndrome, Insulin Resistance, Hypertension

Intervention / Treatment
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* Dietary Supplement: Montmorency Tart Cherry Capsules
* Dietary Supplement: Montmorency Tart Cherry Juice
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Drink<br>Placebo drink attempted to match for total energy, appearance and taste of Montmorency tart cherry juice. | Dietary Supplement: Placebo<br>* 130ml serving Placebo composition: Water (100ml), Cherry Cordial Concentrate (30ml), Citric Acid (1.5g), Maltodextrin (24.75g), Black Food Colouring (2ml).<br>|
| Experimental: Montmorency Tart Cherry Capsules<br>10 capsules consumed to match total anthocyanin content to Montmorency tart cherry juice. | Dietary Supplement: Montmorency Tart Cherry Capsules<br>* 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.<br>|
| Experimental: Montmorency Tart Cherry Juice<br>Single-bolus of Montmorency tart cherry juice (130 mL) | Dietary Supplement: Montmorency Tart Cherry Juice<br>* 100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water. Concentrate contains no sweeteners, preservatives, flavourings or added sugar.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fasting Insulin |  | Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr) | 
| Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL) |  | Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr) | 
| Change in Fasting Glucose |  | Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr) | 
| Change in Systolic and Diastolic Blood Pressure |  | Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Augmentation Index | Measure of arterial stiffness and central blood pressures | Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr) | 
| Change in Aortic Systolic and Diastolic Pressure | Measure of arterial stiffness and central blood pressures | Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr) | 
| Change in Augmentation Pressure | Measure of arterial stiffness and central blood pressures | Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr) | 
| Change in Cardiac Output | Beat-to-beat resting cardiac haemodynamics (cardiac output, mean arterial pressure, strove volume, total peripheral resistance, heart rate) | Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr) | 
| Change in Stroke Volume | Beat-to-beat resting cardiac haemodynamics | Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr) | 
| Change in Heart Rate | Beat-to-beat resting cardiac haemodynamics | Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr) | 
| Change in Mean Arterial Pressure | Beat-to-beat resting cardiac haemodynamics | Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr) | 
| Change in Total Peripheral Resistance | Beat-to-beat resting cardiac haemodynamics | Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr) | 
| Change in Resting Energy Expenditure | Measured from indirect calorimetry | Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr) | 
| Change in Respiratory Quotient | Measured from indirect calorimetry | Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Montmorency Tart Cherry, Anthocyanins, Polyphenols, Metabolic Syndrome, Insulin Resistance, Hypertension, Lipid Profile