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Completed

NCT Number: NCT03619941

Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants

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.

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Key information

Conditions

Metabolic Syndrome Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hertfordshire

Hatfield, Hertfordshire, AL10 9AB, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

  • 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).

Treatment and study plan

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

Placebo drink attempted to match for total energy content, macronutrient content, appearance and taste of Montmorency tart cherry juice.

Primary outcomes

  1. Change in Fasting Insulin

    Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)

  2. Change in Systolic and Diastolic Blood Pressure

    Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)

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

    Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)

  4. Change in Fasting Glucose

    Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)

Secondary outcomes

  1. Change in 24-hour Ambulatory Blood Pressure

    Time frame: Baseline, Post-Supplementation (7 days)

    Systolic, Diastolic and Pulse Pressure will be measured

  2. Change in HOMA2-IR, HOMA%S and HOMA%B

    Time frame: Baseline, Post-Supplementation (7 days)

    Homeostatic Model Assessment of Insulin Resistance, Sensitivity and Beta-cell function

  3. Change in Pulse Wave Analysis

    Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)

  4. Change in Cardiac Haemodynamics

    Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)

    Beat-by-beat cardiac output, stroke volume, heart rate, total peripheral resistance, mean arterial pressure will be measured

  5. Change in Resting Metabolic Rate

    Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)

  6. Change in Angiotensin Converting Enzyme Inhibition activity

    Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)

Sponsors and collaborators

Lead sponsor

University of Hertfordshire

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 8, 2018
Registry last updated
Feb 19, 2019

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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