Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants

Study Overview
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Brief Summary
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The present study examined the effect of Montmorency tart cherry juice on functional and blood-based cardio-metabolic markers in humans with Metabolic Syndrome. Participants consumed Montmorency tart cherry juice or a placebo beverage continuously for 7 days in a randomised, crossover trial. Outcome variables were measured immediately prior to supplementation and post-supplementation. Furthermore, on the 7th day of supplementation outcome variables were measured pre- and up to 5 hours post-bolus. It was hypothesised that Montmorency tart cherry juice would improve cardio-metabolic markers, particularly fasting insulin and systolic blood pressure. Furthermore, the study aimed to identify the mechanism of action for any effects of Montmorency tart cherry juice on blood pressure.

Official Title
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Effects of 7-day Continuous Montmorency Tart Cherry Juice Supplementation in Metabolic Syndrome Participants: a Pilot Study

Conditions
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Metabolic Syndrome, Insulin Resistance, Hypertension

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: Smokers Current or previous history of gastrointestinal, cardiovascular, hepatic or renal disease Currently diagnosed with diabetes or uncontrolled hypertension (≥160/100 mmHg) Allergy to fructose, maltodextrin or specific fruit products Currently taking medication (such as steroids, NSAIDs, antibiotics, antihypertensive, hypoglycaemic, lipid-lowering drugs) 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: 70 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<br> | Dietary Supplement: Placebo<br>* Placebo drink attempted to match for total energy content, macronutrient content, appearance and taste of Montmorency tart cherry juice.<br>|
| Experimental: Montmorency Tart Cherry Juice<br> | 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 |  | Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour) | 
| Change in Systolic and Diastolic Blood Pressure |  | Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour) | 
| Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL) |  | Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour) | 
| Change in Fasting Glucose |  | Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour Ambulatory Blood Pressure | Systolic, Diastolic and Pulse Pressure will be measured | Baseline, Post-Supplementation (7 days) | 
| Change in HOMA2-IR, HOMA%S and HOMA%B | Homeostatic Model Assessment of Insulin Resistance, Sensitivity and Beta-cell function | Baseline, Post-Supplementation (7 days) | 
| Change in Pulse Wave Analysis |  | Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour) | 
| Change in Cardiac Haemodynamics | Beat-by-beat cardiac output, stroke volume, heart rate, total peripheral resistance, mean arterial pressure will be measured | Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour) | 
| Change in Resting Metabolic Rate |  | Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour) | 
| Change in Angiotensin Converting Enzyme Inhibition activity |  | Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour) | 

 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, Prediabetes