Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants

N/ACompletedNCT03619941

University of Hertfordshire12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Metabolic Syndrome Insulin Resistance Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Change in Fasting Insulin

Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)

Change in Systolic and Diastolic Blood Pressure

Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)

Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)

Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)

Change in Fasting Glucose

Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)

Secondary Outcomes

Change in 24-hour Ambulatory Blood Pressure

Systolic, Diastolic and Pulse Pressure will be measured

Time frame: Baseline, Post-Supplementation (7 days)

Change in HOMA2-IR, HOMA%S and HOMA%B

Homeostatic Model Assessment of Insulin Resistance, Sensitivity and Beta-cell function

Time frame: Baseline, Post-Supplementation (7 days)

Change in Pulse Wave Analysis

Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)

Change in Cardiac Haemodynamics

Beat-by-beat cardiac output, stroke volume, heart rate, total peripheral resistance, mean arterial pressure will be measured

Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)

Change in Resting Metabolic Rate

Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)

Change in Angiotensin Converting Enzyme Inhibition activity

Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)

Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes