Hypertension Clinical Trial
Official title:
Effects of 7-day Continuous Montmorency Tart Cherry Juice Supplementation in Metabolic Syndrome Participants: a Pilot Study
Verified date | February 2019 |
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 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.
Status | Completed |
Enrollment | 12 |
Est. completion date | September 29, 2018 |
Est. primary completion date | September 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 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: - 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). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Hertfordshire | Hatfield | Hertfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Hertfordshire |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Fasting Insulin | Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour) | ||
Primary | 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) | ||
Primary | 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) | ||
Primary | Change in Fasting Glucose | Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour) | ||
Secondary | Change in 24-hour Ambulatory Blood Pressure | Systolic, Diastolic and Pulse Pressure will be measured | Baseline, Post-Supplementation (7 days) | |
Secondary | 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) | |
Secondary | 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) | ||
Secondary | 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) | |
Secondary | 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) | ||
Secondary | Change in Angiotensin Converting Enzyme Inhibition activity | Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour) |
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