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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Metabolic Syndrome; Insulin Resistance
• Intervention / Treatment: Dietary supplement: Montmorency Tart Cherry Juice; Dietary supplement: Placebo; Dietary supplement: Montmorency Tart Cherry Capsules

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hatfield, United Kingdom, AL10 9AB
    • University of Hertfordshire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-smoker,

Meet 3 of 5 criteria for Metabolic Syndrome based on National Cholesterol Education Program-Adult Treatment Panel III guidelines:

1. Waist Circumference: >102cm (men), >88cm (women)
2. Fasting Serum Triglycerides: ≥1.69 mmol.L-1
3. Fasting High Density Lipoprotein: <1.03 mmol.L-1 (men), <1.29 mmol.L-1 (women)
4. Blood Pressure: ≥130 mmHg SBP or ≥85 mmHg DBP
5. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: University of Hertfordshire
• Collaborators: Heart UK

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): October 15, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Hypertension; Insulin Resistance; Metabolic Syndrome; Polyphenols; Anthocyanins; Lipid Profile; Montmorency Tart Cherry
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Hyperinsulinism; Hypertension; Syndrome; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: LMS/PGT/UH/02843

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No