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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615885
• Other study ID #: LMS/PGT/UH/02843
• Status: Completed
• Phase: N/A
• Start date: June 6, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: July 2018
• Source: University of Hertfordshire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 1, 2017
• Est. primary completion date: October 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hypertension
• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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.
• Montmorency Tart Cherry Juice
100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water. Concentrate contains no sweeteners, preservatives, flavourings or added sugar.
• Placebo
130ml serving Placebo composition: Water (100ml), Cherry Cordial Concentrate (30ml), Citric Acid (1.5g), Maltodextrin (24.75g), Black Food Colouring (2ml).

Locations

Country	Name	City	State
United Kingdom	University of Hertfordshire	Hatfield

Sponsors (2)

Lead Sponsor	Collaborator
University of Hertfordshire	Heart UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fasting Insulin		Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Primary	Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)		Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Primary	Change in Fasting Glucose		Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Primary	Change in Systolic and Diastolic Blood Pressure		Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary	Change in Augmentation Index	Measure of arterial stiffness and central blood pressures	Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary	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)
Secondary	Change in Augmentation Pressure	Measure of arterial stiffness and central blood pressures	Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary	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)
Secondary	Change in Stroke Volume	Beat-to-beat resting cardiac haemodynamics	Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary	Change in Heart Rate	Beat-to-beat resting cardiac haemodynamics	Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary	Change in Mean Arterial Pressure	Beat-to-beat resting cardiac haemodynamics	Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary	Change in Total Peripheral Resistance	Beat-to-beat resting cardiac haemodynamics	Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary	Change in Resting Energy Expenditure	Measured from indirect calorimetry	Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary	Change in Respiratory Quotient	Measured from indirect calorimetry	Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)