Hypertension Clinical Trial
Official title:
Acute Cardio-metabolic Responses to Different Forms of Montmorency Tart Cherry Supplementation in Humans With Metabolic Syndrome
Verified date | July 2018 |
Source | University of Hertfordshire |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Hertfordshire | Hatfield |
Lead Sponsor | Collaborator |
---|---|
University of Hertfordshire | Heart UK |
United Kingdom,
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) |
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