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Completed

NCT Number: NCT03615885

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

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.

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Key information

Conditions

Metabolic Syndrome Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hertfordshire

Hatfield, AL10 9AB, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-smoker,

Meet 3 of 5 criteria for Metabolic Syndrome based on National Cholesterol Education Program-Adult Treatment Panel III guidelines:

  • Waist Circumference: >102cm (men), >88cm (women)
  • Fasting Serum Triglycerides: ≥1.69 mmol.L-1
  • Fasting High Density Lipoprotein: <1.03 mmol.L-1 (men), <1.29 mmol.L-1 (women)
  • Blood Pressure: ≥130 mmHg SBP or ≥85 mmHg DBP
  • 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).

Treatment and study plan

Montmorency Tart Cherry Capsules

Dietary Supplement

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

Dietary Supplement

100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water.

Concentrate contains no sweeteners, preservatives, flavourings or added sugar.

Placebo

Dietary Supplement

130ml serving

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

Primary outcomes

  1. Change in Fasting Insulin

    Time frame: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)

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

    Time frame: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)

  3. Change in Fasting Glucose

    Time frame: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)

  4. Change in Systolic and Diastolic Blood Pressure

    Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

Secondary outcomes

  1. Change in Augmentation Index

    Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

    Measure of arterial stiffness and central blood pressures

  2. Change in Aortic Systolic and Diastolic Pressure

    Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

    Measure of arterial stiffness and central blood pressures

  3. Change in Augmentation Pressure

    Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

    Measure of arterial stiffness and central blood pressures

  4. Change in Cardiac Output

    Time frame: Pre-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)

  5. Change in Stroke Volume

    Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

    Beat-to-beat resting cardiac haemodynamics

  6. Change in Heart Rate

    Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

    Beat-to-beat resting cardiac haemodynamics

  7. Change in Mean Arterial Pressure

    Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

    Beat-to-beat resting cardiac haemodynamics

  8. Change in Total Peripheral Resistance

    Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

    Beat-to-beat resting cardiac haemodynamics

  9. Change in Resting Energy Expenditure

    Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

    Measured from indirect calorimetry

  10. Change in Respiratory Quotient

    Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

    Measured from indirect calorimetry

Sponsors and collaborators

Lead sponsor

University of Hertfordshire

Other

Collaborators

  • Heart UK

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 6, 2018
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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