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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03619941
Other study ID # LMS/PGR/UH/03319
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


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)
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