Clinical trial NCT03615885: Acute Cardio-metabolic Responses to Montmorency Tart Cherry Supplementation in Metabolic Syndrome Patients
Official title: Acute Cardio-metabolic Responses to Different Forms of Montmorency Tart Cherry Supplementation in Humans With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Insulin Resistance
Hypertension
Keywords: Montmorency Tart Cherry
Anthocyanins
Polyphenols
Metabolic Syndrome
Insulin Resistance
Hypertension
Lipid Profile
Lead sponsor: University of Hertfordshire
Sponsor class: OTHER
Collaborators: name: Heart UK
First posted: 2018-08-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Fasting Insulin
timeFrame: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
measure: Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)
timeFrame: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
measure: Change in Fasting Glucose
timeFrame: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
measure: Change in Systolic and Diastolic Blood Pressure
timeFrame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary outcomes:
measure: Change in Augmentation Index
timeFrame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
measure: Change in Aortic Systolic and Diastolic Pressure
timeFrame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
measure: Change in Augmentation Pressure
timeFrame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
measure: Change in Cardiac Output
timeFrame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
measure: Change in Stroke Volume
timeFrame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
measure: Change in Heart Rate
timeFrame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
measure: Change in Mean Arterial Pressure
timeFrame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
measure: Change in Total Peripheral Resistance
timeFrame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
measure: Change in Resting Energy Expenditure
timeFrame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
measure: Change in Respiratory Quotient
timeFrame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Other outcomes:
Locations:
city: Hatfield
country: United Kingdom
facility: University of Hertfordshire
Study officials:
References: