Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants

Hypertension Clinical Trial

Official title:

Effects of 7-day Continuous Montmorency Tart Cherry Juice Supplementation in Metabolic Syndrome Participants: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619941
• Other study ID #: LMS/PGR/UH/03319
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: September 29, 2018

Study information

• Verified date: February 2019
• Source: University of Hertfordshire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Hypertension
• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Montmorency Tart Cherry Juice
100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water. Concentrate contains no sweeteners, preservatives, flavourings or added sugar.
• Placebo
Placebo drink attempted to match for total energy content, macronutrient content, appearance and taste of Montmorency tart cherry juice.

Locations

Country	Name	City	State
United Kingdom	University of Hertfordshire	Hatfield	Hertfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Hertfordshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

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)