Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03615885
Other study ID # LMS/PGT/UH/02843
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 6, 2017
Est. completion date December 1, 2017

Study information

Verified date July 2018
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 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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date December 1, 2017
Est. primary completion date October 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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).

Study Design


Intervention

Dietary Supplement:
Montmorency Tart Cherry Capsules
Capsules are made from 100% natural, tart Montmorency cherries. Carefully prepared Montmorency cherry skins are freeze-dried and milled into a fine powder to protect the cherry phytonutrients and optimise absorbtion. This powder is then encapsulated into a 100% vegetarian shell.
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
130ml serving Placebo composition: Water (100ml), Cherry Cordial Concentrate (30ml), Citric Acid (1.5g), Maltodextrin (24.75g), Black Food Colouring (2ml).

Locations

Country Name City State
United Kingdom University of Hertfordshire Hatfield

Sponsors (2)

Lead Sponsor Collaborator
University of Hertfordshire Heart UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Fasting Insulin Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Primary Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL) Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Primary Change in Fasting Glucose Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Primary Change in Systolic and Diastolic Blood Pressure Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary Change in Augmentation Index Measure of arterial stiffness and central blood pressures Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary Change in Aortic Systolic and Diastolic Pressure Measure of arterial stiffness and central blood pressures Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary Change in Augmentation Pressure Measure of arterial stiffness and central blood pressures Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary Change in Cardiac Output Beat-to-beat resting cardiac haemodynamics (cardiac output, mean arterial pressure, strove volume, total peripheral resistance, heart rate) Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary Change in Stroke Volume Beat-to-beat resting cardiac haemodynamics Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary Change in Heart Rate Beat-to-beat resting cardiac haemodynamics Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary Change in Mean Arterial Pressure Beat-to-beat resting cardiac haemodynamics Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary Change in Total Peripheral Resistance Beat-to-beat resting cardiac haemodynamics Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary Change in Resting Energy Expenditure Measured from indirect calorimetry Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Secondary Change in Respiratory Quotient Measured from indirect calorimetry Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A