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Acute Cardio-metabolic Responses to Montmorency Tart Cherry Supplementation in Metabolic Syndrome Patients

Acute Cardio-metabolic Responses to Different Forms of Montmorency Tart Cherry Supplementation in Humans With Metabolic Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03615885
Enrollment
11
Registered
2018-08-06
Start date
2017-06-06
Completion date
2017-12-01
Last updated
2018-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Insulin Resistance, Metabolic Syndrome

Keywords

Montmorency Tart Cherry, Anthocyanins, Polyphenols, Metabolic Syndrome, Insulin Resistance, Hypertension, Lipid Profile

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.

Interventions

DIETARY_SUPPLEMENTMontmorency 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.

100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water. Concentrate contains no sweeteners, preservatives, flavourings or added sugar.

DIETARY_SUPPLEMENTPlacebo

130ml serving Placebo composition: Water (100ml), Cherry Cordial Concentrate (30ml), Citric Acid (1.5g), Maltodextrin (24.75g), Black Food Colouring (2ml).

Sponsors

Heart UK
CollaboratorUNKNOWN
University of Hertfordshire
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Change in Fasting InsulinPre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Change in Fasting GlucosePre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Change in Systolic and Diastolic Blood PressurePre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

Secondary

MeasureTime frameDescription
Change in Stroke VolumePre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)Beat-to-beat resting cardiac haemodynamics
Change in Heart RatePre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)Beat-to-beat resting cardiac haemodynamics
Change in Mean Arterial PressurePre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)Beat-to-beat resting cardiac haemodynamics
Change in Augmentation IndexPre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)Measure of arterial stiffness and central blood pressures
Change in Resting Energy ExpenditurePre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)Measured from indirect calorimetry
Change in Respiratory QuotientPre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)Measured from indirect calorimetry
Change in Total Peripheral ResistancePre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)Beat-to-beat resting cardiac haemodynamics
Change in Aortic Systolic and Diastolic PressurePre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)Measure of arterial stiffness and central blood pressures
Change in Augmentation PressurePre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)Measure of arterial stiffness and central blood pressures
Change in Cardiac OutputPre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)Beat-to-beat resting cardiac haemodynamics (cardiac output, mean arterial pressure, strove volume, total peripheral resistance, heart rate)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026