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

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Hypertension; Insulin Resistance
• Interventions: Dietary Supplement: Montmorency Tart Cherry Juice; Dietary Supplement: Placebo; Dietary Supplement: Montmorency Tart Cherry Capsules

• Registration Number: NCT03615885
• Lead Sponsor: University of Hertfordshire

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-06
• Primary Completion: 2017-10-15
• Study Completion: 2017-12-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-07-30
• Last Update Submitted: 2018-07-30
• Study First Posted: 2018-08-06
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Montmorency Tart Cherry Juice	Montmorency Tart Cherry Juice	Single-bolus of Montmorency tart cherry juice (130 mL)
Placebo Drink	Placebo	Placebo drink attempted to match for total energy, appearance and taste of Montmorency tart cherry juice.
Montmorency Tart Cherry Capsules	Montmorency Tart Cherry Capsules	10 capsules consumed to match total anthocyanin content to Montmorency tart cherry juice.

Primary Outcome Measures

Name	Time	Method
Change in Fasting Insulin	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)
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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Hertfordshire; 🇬🇧 Hatfield, United Kingdom